Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

• ClinicalTrials.gov Identifier: NCT01175213
• Recruitment Status: Completed
• First Posted: August 4, 2010
• Results First Posted: May 26, 2016
• Last Update Posted: May 19, 2021
• Sponsor: Baxalta now part of Shire
• Information provided by (Responsible Party): Takeda ( Baxalta now part of Shire )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Primary Immunodeficiency Diseases (PID)
• Interventions: Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety); Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety); Biological: IV treatment with IGSC, 10%
• Enrollment: 66

Participant Flow

Recruitment Details	Recruitment was conducted 11 clinical sites in the United States.
Pre-assignment Details	66 participants who enrolled from study 160603 were screened and all were enrolled on the study. Of these, 3 participants were treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only i.e. did not receive rHuPH20 during this study.

Arm/Group Title	IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only	IGIV, 10% Only
Arm/Group Description	Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator. Note: IGIV, 10% is the same product as IGSC, 10%.	Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study. Note: IGIV, 10% is the same product as IGSC, 10%.
Period Title: IGSC, 10%/rHuPH20
Started	63	3 [1]
Completed	48	3
Not Completed	15	0
Reason Not Completed
Withdrawal by Subject	4	0
Death	1	0
bone marrow transplant	1	0
clinical site closed by sponsor	6	0
site elected to exit study	3	0
[1] 3 participants treated IV with IGIV,10% without rHuPH20 throughout the study.
Period Title: Safety Follow-up
Started	48	3
Completed	47	3
Not Completed	1	0
Reason Not Completed
Adverse Event	1	0

Baseline Characteristics

Arm/Group Title		Participants Aged 2 to <12 Years	Participants Aged 12 to <16 Years	Participants Aged 16 to <65 Years	Participants Aged 65 Years and Older	Total
Arm/Group Description		[Not Specified]	[Not Specified]	[Not Specified]	[Not Specified]	Total of all reporting groups
Overall Number of Baseline Participants		4	7	47	8	66
Baseline Analysis Population Description		Safety Analysis Set
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	4 participants	7 participants	47 participants	8 participants	66 participants
		10.5; (9 to 11)	15.0; (13 to 15)	47.0; (16 to 64)	71.0; (65 to 80)	43.0; (9 to 80)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants	7 participants	47 participants	8 participants	66 participants
	Female	1 25.0%	1 14.3%	23 48.9%	7 87.5%	32 48.5%
	Male	3 75.0%	6 85.7%	24 51.1%	1 12.5%	34 51.5%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	4 participants	7 participants	47 participants	8 participants	66 participants
		4 100.0%	7 100.0%	47 100.0%	8 100.0%	66 100.0%

Outcome Measures

1. Primary Outcome

Title	Annual Rate of Serious Bacterial Infections
Description	The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time Frame	Throughout the efficacy period only (from 60 to 729 days)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20

Arm/Group Title	All Participants Treated With IGSC, 10% and rHuPH20
Arm/Group Description:	Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20.
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: Estimated infections/year
	0.020

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants Treated With IGSC, 10% and rHuPH20
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
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	[Not Specified]
Method of Estimation	Estimation Parameter	Poisson
	Estimated Value	0.020
	Confidence Interval	(1-Sided) 99%; 0.045
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Annual Rate of All Infections
Description	Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) "infections and infestations". The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time Frame	Throughout the efficacy period only (from 60 to 729 days)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20

Arm/Group Title	All Participants Treated With IGSC, 10% and rHuPH20
Arm/Group Description:	Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20.
Overall Number of Participants Analyzed	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Number of infections/year
	2.86; (2.36 to 3.43)

3. Primary Outcome

Title	Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency
Description	Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals). Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) [or IV infusions of IGSC, 10% only] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals). After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG. This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time Frame	Throughout the efficacy period only (from 60 to 729 days)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	All Participants Treated With rHuPH20 and/or IGSC, 10%
Arm/Group Description:	All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20). This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only. Number of participants in each treatment interval [N] is provided.
Overall Number of Participants Analyzed	66
Median (95% Confidence Interval); Unit of Measure: g/L
2-Week Treatment Interval [N=17]	10.900; (9.390 to 13.300)
3-Week Treatment Interval [N=9]	12.300; (11.500 to 15.300)
4-Week Treatment Interval [N=47]	9.760; (9.260 to 10.700)

4. Secondary Outcome

Title	The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs
Description	Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20).
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: SAEs/year
Participants aged 2 to <12 years - not related	0.0000	0.0000
Participants aged 2 to <12 years - related	0.0000	0.0000
Participants aged 12 to <16 years - not related	0.0768	0.0000
Participants aged 12 to <16 years - related	0.0000	0.0000
Participants aged 16 to <65 years - not related	0.0950	0.0449
Participants aged 16 to <65 years - related	0.0000	0.0000
Participants aged 65 years and older- not related	0.5737	0.4728
Participants aged 65 years and older- related	0.0000	0.0000

5. 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 AEs
Description	[Not Specified]
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Percentage of infusions
Percentage of infusion rates reduced	1.3	0.3
Percentage of infusions interrupted	0.8	0.2
Percentage of infusions stopped	0.1	0.2

6. Secondary Outcome

Title	Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion
Description	[Not Specified]
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Percentage of infusions
Including Infections	3.4	4.7
Excluding Infections	2.9	4.0

7. Secondary Outcome

Title	Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20
Description	Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603.
Time Frame	Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

Outcome Measure Data

Analysis Population Description

Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20

Arm/Group Title	All Participants Treated With rHuPH20
Arm/Group Description:	All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
Overall Number of Participants Analyzed	66
Measure Type: Number; Unit of Measure: Number of participants
Binding antibodies (>=1:160)	13
Neutralizing antibodies	0

8. Secondary Outcome

Title	Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20
Description	Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603.
Time Frame	Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

Outcome Measure Data

Analysis Population Description

Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20

Arm/Group Title	All Participants Treated With rHuPH20
Arm/Group Description:	All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
Overall Number of Participants Analyzed	66
Measure Type: Number; Unit of Measure: Percentage of participants
Binding antibodies (>=1:160)	19.7
Neutralizing antibodies	0

9. Secondary Outcome

Title	Number of Participants With AEs Related to Anti-rHuPH20 Titers
Description	[Not Specified]
Time Frame	Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

Outcome Measure Data

Analysis Population Description

All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.

Arm/Group Title	All Participants Treated With rHuPH20
Arm/Group Description:	All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
Overall Number of Participants Analyzed	13
Measure Type: Number; Unit of Measure: Number of participants
	12

10. Secondary Outcome

Title	Percentage of Participants With AEs Related to Anti-rHuPH20 Titers
Description	[Not Specified]
Time Frame	Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

Outcome Measure Data

Analysis Population Description

All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.

Arm/Group Title	All Participants Treated With rHuPH20
Arm/Group Description:	All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
Overall Number of Participants Analyzed	13
Measure Type: Number; Unit of Measure: Percentage of participants
	92.3

11. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the 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 Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs
Abdominal Distension-non-SAE-R-Mild	6	0
Abdominal Hernia-non-SAE-NR-Mild	1	0
Abdominal Mass-non-SAE-NR-Mild	0	1
Abdominal Pain-non-SAE-NR-Mild	2	1
Abdominal Pain-non-SAE-NR-Mod	4	0
Abdominal Pain-non-SAE-NR-Severe	1	0
Abdominal Pain-non-SAE-R-Mild	0	3
Abdominal Pain Upper-non-SAE-NR-Mild	7	0
Abdominal Pain Upper-non-SAE-R-Mild	1	0
Abdominal Tenderness-non-SAE-NR-Mild	2	0
Abdominal Tenderness-non-SAE-R-Mild	1	0
Abnormal Loss Of Weight-non-SAE-NR-Mild	1	0
Acarodermatitis-non-SAE-NR-Mild	2	1
Acarodermatitis-non-SAE-NR-Mod	2	0
Acne-non-SAE-NR-Mild	1	0
Acne-non-SAE-NR-Mod	1	0
Actinic Keratosis-non-SAE-NR-Mild	1	0
Actinic Keratosis-non-SAE-NR-Mod	1	2
Activities of Daily Living Impaired-non-SAE-NR-Mod	1	0
Acute Sinusitis-non-SAE-NR-Mild	0	1
Acute Sinusitis-non-SAE-NR-Mod	1	0
Acute Stress Disorder-non-SAE-NR-Mild	1	0
Adhesiolysis-SAE-NR-Mod	1	0
Age Related Macular Degeneration-non-SAE-NR-Mild	1	0
Agitation-non-SAE-NR-Mild	1	0
Aldolase Increased-non-SAE-NR-Mild	1	0
Anaphylactic Reaction-non-SAE-R-Sev	0	1
Animal Bite-non-SAE-NR-Mild	1	0
Animal Scratch-non-SAE-NR-Mild	0	1
Anxiety-non-SAE-NR-Mild	2	0
Anxiety-non-SAE-NR-Mod	2	0
Aortic Calcification-non-SAE-NR-Mild	1	0
Aortic Stenosis-non-SAE-NR-Mild	1	0
Aortic Stenosis-non-SAE-NR-Mod	1	0
Aortic Valve Incompetence-non-SAE-NR-Mod	1	0
Aortic Valve Incompetence-SAE-NR-Sev	1	0
Apthous Stomatitis-non-SAE-NR-Mild	4	2
Apthous Stomatitis-non-SAE-NR-Mod	2	0
Apthous Stomatitis-non-SAE-R-Mild	1	0
Appendicitis-SAE-NR-Mod	1	0
Application Site Erythema-non-SAE-NR-Mild	1	0
Arteritis-non-SAE-NR-Mod	1	0
Arthralgia-non-SAE-NR-Mild	7	1
Arthralgia-non-SAE-NR-Mod	0	6
Arthralgia-non-SAE-R-Mild	1	0
Arthropod Bite-non-SAE-NR-Mild	1	1
Asthenia-non-SAE-NR-Mild	1	0
Asthenia-non-SAE-NR-Mod	2	0
Asthenia-non-SAE-R-Mild	6	0
Asthenia-non-SAE-R-Mod	7	1
Asthma-non-SAE-NR-Mild	12	3
Asthma-non-SAE-NR-Mod	20	3
Ataxia-non-SAE-NR-Mild	2	0
Atelectasis-non-SAE-NR-Mild	1	0
Atrial Fibrillation-non-SAE-NR-Mild	1	0
Atrial Fibrillation-SAE-NR-Mod	1	0
ADHD-non-SAE-NR-Mod	1	0
Back Pain-non-SAE-NR-Mild	3	2
Back Pain-non-SAE-NR-Mod	3	2
Back Pain-non-SAE-R-Sev	0	1
Basal Cell Carcinoma-non-SAE-NR-Mild	1	0
Basal Cell Carcinoma-non-SAE-NR-Mod	4	1
Blepharochalasis-non-SAE-NR-Mild	1	0
Blister-non-SAE-NR-Mild	1	0
Blood Bicarbonate Decreased-non-SAE-NR-Mild	1	0
Blood CPK Increased-non-SAE-NR-Mild	3	0
Blood CPK Increased-non-SAE-NR-Mod	2	0
Blood Creatinine Increased-non-SAE-NR-Mild	1	0
Blood Creatinine Increased-non-SAE-R-Mild	0	1
Blood Glucose Increased-non-SAE-NR-Mild	4	1
Blood Urea Increased-non-SAE-R-Mild	0	1
Blood Urine Present-non-SAE-NR-Mild	2	0
Body Tinea-non-SAE-NR-Mild	2	0
Bone Pain-non-SAE-NR-Mild	1	0
Breast Calcifications-non-SAE-NR-Mild	1	0
Breast Dysplasia-non-SAE-NR-Mild	0	1
Bronchiolitis-non-SAE-NR-Mild	1	0
Bronchitis-non-SAE-NR-Mild	11	5
Bronchitis-non-SAE-NR-Mod	11	2
Burns Second Degree-non-SAE-NR-Mild	1	0
Bursitis-non-SAE-NR-Mild	2	0
Candidiasis-non-SAE-NR-Mild	1	0
Cardiac Failure Congestive-SAE-NR-Mild	1	0
Cardiac Murmur-non-SAE-NR-Mod	2	0
Cardiomegaly-non-SAE-NR-Mild	0	1
Cardiomegaly-non-SAE-NR-Mod	2	0
Cardiomyopathy-non-SAE-NR-Mild	1	0
Cataract-non-SAE-NR-Mild	1	1
Cataract-non-SAE-NR-Mod	2	0
Cellulitis-non-SAE-NR-Mild	2	0
Cellulitis-non-SAE-NR-Mod	2	1
Cellulitis-SAE-NR-Mod	0	1
Cellulitis Male Ext. Genital Organ-non-SAE-NR-Mod	1	0
Cerebral Sml Vessel Ischaemic Dis-non-SAE-NR-Mild	1	0
Cerumen Impaction-non-SAE-NR-Mild	2	2
Cervical Spinal Stenosis-non-SAE-NR-Mild	0	1
Chapped Lips-non-SAE-NR-Mild	1	0
Cheilitis-non-SAE-NR-Mild	1	0
Chest Discomfort-non-SAE-NR-Mild	1	0
Chest Pain-non-SAE-NR-Mild	2	0
Chest Pain-non-SAE-NR-Mod	1	0
Chills-non-SAE-NR-Mild	2	0
Chills-non-SAE-NR-Mod	1	0
Chills-non-SAE-R-Mild	11	1
Cholelithiasis-non-SAE-NR-Mild	2	0
Chondromalacia-non-SAE-NR-Mod	1	0
Chromaturia-non-SAE-NR-Mild	1	0
COPD-non-SAE-NR-Mild	2	0
COPD-non-SAE-NR-Mod	3	0
COPD-SAE-NR-Mod	1	0
COPD-SAE-NR-Sev	1	0
Chronic Sinusitis-non-SAE-NR-Mild	5	2
Chronic Sinusitis-non-SAE-NR-Mod	3	1
Conjunctival Haemorrhage-non-SAE-NR-Mild	1	0
Conjunctival Hyperaemia-non-SAE-NR-Mild	2	0
Conjunctivitis-non-SAE-NR-Mild	0	2
Conjunctivitis Allergic-non-SAE-NR-Mild	1	1
Conjunctivitis Allergic-non-SAE-NR-Mod	0	2
Conjunctivitis Infective-non-SAE-NR-Mild	3	1
Constipation-non-SAE-NR-Mild	3	3
Constipation-non-SAE-NR-Mod	3	0
Contusion-non-SAE-NR-Mild	0	3
Convulsion-non-SAE-NR-Mild	1	0
Convulsion-non-SAE-NR-Mod	2	1
Coombs Direct Test Positive-non-SAE-R-Mild	1	0
Coombs Test Positive-non-SAE-NR-Mild	1	0
Coombs Test Positive-non-SAE-R-Mild	1	0
Corneal Abrasion-non-SAE-NR-Mild	1	0
Costochondritis-non-SAE-NR-Mild	1	0
Costochondritis-non-SAE-NR-Sev	1	0
Cough-non-SAE-NR-Mild	10	3
Cough-non-SAE-NR-Mod	3	1
Cough-non-SAE-R-Mild	1	0
Cryptosporidiosis Infection-SAE-NR-Sev	1	0
Cyst-non-SAE-NR-Mild	1	0
Cyst-non-SAE-NR-Mod	2	0
Cystitis-non-SAE-NR-Mild	1	0
Cystocele-SAE-NR-Mod	1	0
Decreased Appetite-non-SAE-NR-Mild	1	0
Decreased Appetite-non-SAE-NR-Mod	2	0
Decreased Appetite-non-SAE-R-Mild	3	8
Dehydration-non-SAE-NR-Mild	1	0
Dehydration-non-SAE-NR-Mod	1	0
Dental Caries-non-SAE-NR-Mod	2	0
Depression-non-SAE-NR-Mild	1	0
Depression-non-SAE-NR-Mod	3	1
Dermal Cyst-non-SAE-NR-Mod	1	0
Dermatitis-non-SAE-NR-Mild	1	0
Dermatitis Allergic-non-SAE-NR-Mild	0	1
Dermatitis Atopic-non-SAE-NR-Mild	1	0
Dermatitis Contact-non-SAE-NR-Mild	3	0
Dermatitis Contact-non-SAE-NR-Mod	1	0
Dermatitis Psoriasiform-non-SAE-NR-Sev	1	0
Device Breakage-non-SAE-NR-Mod	1	0
Device Failure-non-SAE-NR-Mod	1	0
Diarrhoea-non-SAE-NR-Mild	15	4
Diarrhoea-non-SAE-NR-Mod	2	0
Diarrhoea-non-SAE-R-Mild	2	1
Dizziness-non-SAE-NR-Mild	5	1
Dizziness-non-SAE-R-Mild	5	0
Dizziness-non-SAE-R-Mod	1	0
Drug Eruption-non-SAE-NR-Mod	1	0
Drug Hypersensitivity-non-SAE-NR-Mild	3	0
Dry Eye-non-SAE-NR-Mild	1	0
Dry Eye-non-SAE-NR-Mod	1	1
Dry Mouth-non-SAE-NR-Mild	0	1
Dry Skin-non-SAE-NR-Mild	0	1
Dysmenorrhoea-non-SAE-NR-Mild	1	0
Dyspepsia-non-SAE-NR-Mild	0	3
Dysplastic Naevus-non-SAE-NR-Mod	1	0
Dyspnoea-non-SAE-NR-Mild	2	1
Dyspnoea-non-SAE-NR-Mod	2	0
Dysuria-non-SAE-NR-Mild	1	1
Dysuria-non-SAE-NR-Mod	2	0
Ear Infection-non-SAE-NR-Mild	1	0
Ear Infection-non-SAE-NR-Mod	3	0
Ear Pain-non-SAE-NR-Mild	1	0
Ear Pain-non-SAE-NR-Mod	2	0
Ear Pruritus-non-SAE-R-Mild	0	1
Eccymosis-non-SAE-NR-Mild	3	0
Eccymosis-non-SAE-NR-Mod	0	1
Eczema-non-SAE-NR-Mild	0	2
Eczema-non-SAE-NR-Mod	5	0
Empty Sella Syndrome-non-SAE-NR-Mild	1	0
Epilepsy-non-SAE-NR-Mod	1	0
Epitaxis-non-SAE-NR-Mild	11	5
Erythema-non-SAE-NR-Mild	1	0
Eschar-non-SAE-NR-Mild	1	0
Excoriation-non-SAE-NR-Mild	8	1
Excoriation-non-SAE-NR-Mod	1	0
Eye Haemorrhage-non-SAE-NR-Mild	1	0
Eye Infection-non-SAE-NR-Mild	1	1
Eye Pain-non-SAE-NR-Mild	0	1
Eye Swelling-non-SAE-NR-Mild	1	0
Eyelid Ptosis-non-SAE-NR-Mild	1	0
Facial Bones Fracture-non-SAE-NR-Mod	0	1
Facial Pain-non-SAE-NR-Mod	1	0
Fall-non-SAE-NR-Mild	3	1
Fall-non-SAE-NR-Sev	0	1
Fatigue-non-SAE-NR-Mild	7	1
Fatigue-non-SAE-NR-Mod	3	1
Fatigue-non-SAE-NR-Severe	1	0
Fatigue-non-SAE-R-Mild	13	14
Fatigue-non-SAE-R-Mod	3	7
Femur Fracture-SAE-NR-Sev	0	1
Fibromyalgia-non-SAE-NR-Mod	2	1
Flatulence-non-SAE-NR-Mod	1	0
Flushing-non-SAE-NR-Mod	1	0
Folliculitis-non-SAE-NR-Mild	1	0
Food Poisoning-non-SAE-NR-Mild	2	0
Food Poisoning-non-SAE-NR-Mod	1	0
Foot Fracture-non-SAE-NR-Mod	1	0
Free Haemoglobin Present-non-SAE-NR-Mild	1	0
Free Haemoglobin Present-non-SAE-NR-Mod	1	0
Free Haemoglobin Present-non-SAE-R-Mild	1	0
Free Haemoglobin Present-non-SAE-R-Mod	1	0
Frequent Bowel Movements-non-SAE-NR-Mod	1	0
Fungal Infection-non-SAE-NR-Mild	1	1
Fungal Skin Infection-non-SAE-NR-Mild	1	0

12. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the 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 Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs
Gastric Stenosis-non-SAE-NR-Mod	1	0
Gastritis-non-SAE-NR-Mild	1	0
Gastroenteritis-non-SAE-NR-Mild	3	0
Gastroenteritis-non-SAE-NR-Mod	2	0
Gastroenteritis Salmonella-non-SAE-NR-Mod	1	0
Gastroenteritis Viral-non-SAE-NR-Mild	4	1
Gastroenteritis Viral-non-SAE-NR-Mod	3	1
Gastrointestinal Viral Infection-non-SAE-NR-Mild	1	0
Gastrooesophageal Reflux Disease-non-SAE-NR-Mild	3	0
Gastrooesophageal Reflux Disease-non-SAE-NR-Mod	1	0
Genital Herpes-non-SAE-NR-Mild	2	2
Genital Herpes-non-SAE-NR-Mod	0	1
Gingival Erosion-non-SAE-NR-Mild	1	0
Gingivitis-non-SAE-NR-Mild	1	0
Glaucoma-non-SAE-NR-Mod	1	0
Glycosuria-non-SAE-NR-Mild	1	0
Gout-non-SAE-NR-Mod	1	0
Haematochezia-non-SAE-NR-Mild	1	0
Haematospermia-non-SAE-NR-Mild	1	0
Haematuria-non-SAE-NR-Mild	1	1
Haemoglobin Decreased-non-SAE-R-Mild	0	1
Haemolysis-non-SAE-R-Mild	1	0
Haemorrhoids-non-SAE-NR-Mild	2	0
Haemorrhoids-non-SAE-NR-Mod	2	0
Hand Fracture-non-SAE-NR-Mod	1	0
Headache-non-SAE-NR-Mild	22	5
Headache-non-SAE-NR-Mod	4	0
Headache-non-SAE-R-Mild	19	34
Headache-non-SAE-R-Mod	2	2
Heart Rate Irregular-non-SAE-NR-Mild	2	1
Herpes Zoster-non-SAE-NR-Mod	3	0
Hiatus Hernia-non-SAE-NR-Mild	1	0
Hydrocele-non-SAE-NR-Mild	1	0
Hypercapnia-non-SAE-Mild	1	0
Hypercholesterolaemia-non-SAE-NR-Mild	1	0
Hypersensitivity-non-SAE-NR-Mild	2	0
Hypertension-non-SAE-NR-Mild	1	1
Hypertension-non-SAE-NR-Mod	6	0
Hypertension-SAE-NR-Mod	1	0
Hypoaesthesia-non-SAE-NR-Mild	1	0
Hypokalaemia-non-SAE-NR-Mild	0	2
Hypothyroidism-non-SAE-NR-Mild	0	2
Hypothyroidism-non-SAE-NR-Mod	1	0
Impetigo-non-SAE-NR-Mild	2	0
Incision Site Pain-non-SAE-NR-Mod	1	0
Increased Upper Airway Secretion-non-SAE-NR-Mild	1	0
Inflammation Of Wound-non-SAE-NR-Mild	0	1
Influenza-non-SAE-NR-Mod	6	4
Influenza Like Illness-non-SAE-NR-Mild	3	0
Influenza Like Illness-non-SAE-NR-Mod	1	0
Infusion Site Abscess-non-SAE-R-Mild	1	0
Infusion Site Bruising-non-SAE-R-Mild	1	0
Infusion Site Discolouration-non-SAE-R-Mild	1	0
Infusion Site Discomfort-non-SAE-R-Mild	8	2
Infusion Site Erythema-non-SAE-R-Mild	22	0
Infusion Site Erythema-non-SAE-R-Mod	1	0
Infusion Site Induration-non-SAE-R-Mild	2	0
Infusion Site Mass-non-SAE-R-Mild	1	0
Infusion Site Oedema-non-SAE-R-Mild	1	0
Infusion Site Pain-non-SAE-NR-Mod	0	2
Infusion Site Pain-non-SAE-R-Mild	78	17
Infusion Site Pain-non-SAE-R-Mod	6	0
Infusion Site Pruritus-non-SAE-R-Mild	31	0
Infusion Site Swelling-non-SAE-R-Mild	3	0
Infusion Site Swelling-non-SAE-R-Sev	1	0
Injection Site Pain-non-SAE-NR-Mild	1	0
Injection Site Pain-non-SAE-R-Mild	2	0
Insomnia-non-SAE-NR-Mild	5	0
Insomnia-non-SAE-NR-Mod	0	1
Intervertebral Disc Degeneration-non-SAE-NR-Mild	1	0
Iron Deficiency Anaemia-non-SAE-NR-Mild	1	0
Irritable Bowel Syndrome-non-SAE-NR-Mod	2	0
Jejunal Stenosis-non-SAE-NR-Mod	1	0
Joint Dislocation-non-SAE-NR-Sev	1	0
Joint Injury-non-SAE-NR-Mild	2	0
Joint Swelling-non-SAE-NR-Mod	0	1
Laceration-non-SAE-NR-Mild	0	1
Ligament Sprain-non-SAE-NR-Mild	2	0
Ligament Sprain-non-SAE-NR-Mod	1	2
Limb Discomfort-non-SAE-NR-Mild	0	1
Liver Function Test Abnormal-non-SAE-NR-Mild	1	0
Local Swelling-non-SAE-NR-Mild	1	0
Local Swelling-non-SAE-R-Mild	2	0
Localised Infection-non-SAE-NR-Mod	1	0
Loss Of Consciousness-non-SAE-NR-Mild	0	1
Lyme Disease-non-SAE-NR-Mild	2	0
Lymph Gland Infection-non-SAE-NR-Mod	1	0
Lymphadenitis-non-SAE-NR-Mod	0	1
Lymphadenitis Bacterial-non-SAE-NR-Mild	2	0
Lymphadenopathy-non-SAE-NR-Mild	5	2
Lymphopenia-non-SAE-NR-Mild	1	0
Malaise-non-SAE-NR-Mild	2	1
Malaise-non-SAE-R-Mild	1	0
Medical Device Pain-non-SAE-NR-Mild	2	0
Memory Impairment-non-SAE-NR-Mild	1	0
Meniscus Injury-non-SAE-NR-Mild	1	0
Menstrual Disorder-non-SAE-NR-Mod	1	0
Mental Status Changes-SAE-NR-Sev	1	0
Micturition Urgency-non-SAE-NR-Mild	0	1
Middle Ear Effusion-non-SAE-NR-Mild	0	1
Migraine-non-SAE-NR-Mild	3	0
Migraine-non-SAE-NR-Mod	2	4
Migraine-non-SAE-NR-Sev	0	1
Migraine-non-SAE-R-Mild	1	2
Migraine-non-SAE-R-Mod	3	1
Mitral Valve Incompetence-non-SAE-NR-Mild	2	0
Molluscum Contagiosum-non-SAE-NR-Mild	1	1
Mouth Ulceration-non-SAE-NR-Mild	0	1
Mucosal Inflammation-non-SAE-NR-Mild	1	0
Muscle Contractions Involuntary-non-SAE-R-Mild	1	0
Muscle Spasms-non-SAE-NR-Mild	4	0
Muscle Strain-non-SAE-NR-Mild	2	0
Muscular Weakness-non-SAE-NR-Mild	0	1
Muscular Weakness-non-SAE-NR-Mod	1	0
Musculoskeletal Pain-non-SAE-NR-Mild	4	0
Musculoskeletal Pain-non-SAE-NR-Mod	1	1
Myalgia-non-SAE-NR-Mild	2	3
Myalgia-non-SAE-NR-Mod	0	1
Myalgia-non-SAE-R-Mild	23	3
Myalgia-non-SAE-R-Mod	3	1

13. Secondary Outcome

Title	Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the 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 Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Infection - Inf.
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs
Nasal Congestion-non-SAE-NR-Mild	11	5
Nasal Congestion-non-SAE-NR-Mod	2	0
Nasal Discomfort-non-SAE-NR-Mild	1	0
Nasopharyngitis-non-SAE-NR-Mild	7	5
Nasopharyngitis-non-SAE-NR-Mod	1	0
Nausea-non-SAE-NR-Mild	14	5
Nausea-non-SAE-NR-Mod	4	1
Nausea-non-SAE-R-Mild	25	12
Nausea-non-SAE-R-Mod	3	7
Nephrolithiasis-non-SAE-NR-Mild	0	1
Nerve Compression-non-SAE-NR-Mild	0	1
Neutrophil Count Decreased-non-SAE-NR-Mild	0	1
Ocular Hyperaemia-non-SAE-NR-Mild	0	1
Oedema Peripheral-non-SAE-NR-Mild	4	4
Oedema Peripheral-non-SAE-NR-Mod	4	1
Oedema Peripheral-non-SAE-R-Mild	0	1
Oral Candidiasis-non-SAE-NR-Mild	2	0
Oral Herpes-non-SAE-NR-Mild	7	2
Oral Pain-non-SAE-NR-Mild	0	1
Oral Pain-non-SAE-NR-Mod	0	1
Orchitis-non-SAE-NR-Mod	1	0
Oropharyngeal Pain-non-SAE-NR-Mild	4	1
Osteoarthritis-non-SAE-NR-Mild	2	1
Osteoarthritis-non-SAE-NR-Mod	1	0
Osteopenia-non-SAE-NR-Mild	1	0
Osteoporosis-non-SAE-NR-Mild	0	1
Otitis Externa-non-SAE-NR-Mild	1	1
Otitis Externa-non-SAE-NR-Mod	0	1
Otitis Media-non-SAE-NR-Mod	1	1
Pain-non-SAE-NR-Mild	2	0
Pain-non-SAE-R-Mild	7	0
Pain In Extremity-non-SAE-NR-Mild	4	1
Pain In Extremity-non-SAE-R-Sev	0	1
Palpitations-non-SAE-NR-Mild	2	0
Panic Attack-non-SAE-NR-Mild	0	1
Papule-non-SAE-NR-Mild	1	0
Paraesthesia-non-SAE-R-Mild	1	0
Paranasal Cyst-non-SAE-NR-Mild	1	0
Pelvic Pain-non-SAE-NR-Mod	1	0
Pericardial Effusion-non-SAE-NR-Mild	1	0
Perineurial Cyst-non-SAE-NR-Mod	1	0
Periodontal Disease-non-SAE-NR-Mild	1	0
Pharyngitis-non-SAE-NR-Mild	6	1
Pharyngitis-non-SAE-NR-Mod	0	1
Pharyngitis Streptococcal-non-SAE-NR-Mild	1	0
Pleural Effusion-non-SAE-NR-Mild	1	0
Pleural Effusion-non-SAE-NR-Mod	1	0
Pneumonia-non-SAE-NR-Mild	1	0
Pneumonia Bacterial-non-SAE-NR-Mod	1	0
Pneumonia Pseudomonas Aeruginosa-SAE-NR-Sev	1	0
Pollakiuria-non-SAE-NR-Mild	0	1
Pollakiuria-non-SAE-NR-Mod	1	0
Polycystic Ovaries-non-SAE-NR-Mild	0	1
Post Procedural Complication-non-SAE-NR-Mod	1	0
Post Procedural Haemorrhage-non-SAE-NR-Mild	1	0
Post Procedural Swelling-non-SAE-NR-Mild	1	0
Procedural Nausea-non-SAE-NR-Mod	1	0
Procedural Pain-non-SAE-NR-Mild	0	1
Procedural Pain-non-SAE-NR-Mod	9	1
Proctalgia-non-SAE-NR-Mod	1	0
Productive Cough-non-SAE-NR-Mild	2	0
Protein Urine Present-non-SAE-NR-Mild	1	0
Pruritus-non-SAE-NR-Mild	3	3
Pruritus-non-SAE-NR-Mod	1	0
Pruritus-non-SAE-R-Mild	0	3
Pruritus Allergic-non-SAE-NR-Mod	0	1
Pruritus Generalised-non-SAE-R-Mild	0	1
Pulmonary Hypertension-non-SAE-NR-Mild	1	0
Pulmonary Hypertension-non-SAE-NR-Mod	1	0
Pulmonary Vascular Disorder-non-SAE-NR-Mod	1	0
Puncture Site Pain-non-SAE-NR-Mild	0	1
Puncture Site Pain-non-SAE-NR-Mod	0	2
Purpura Senile-non-SAE-NR-Mild	0	1
Pyogenic Granuloma-non-SAE-NR-Mod	1	1
Pyrexia-non-SAE-NR-Mild	11	5
Pyrexia-non-SAE-NR-Mod	2	0
Pyrexia-non-SAE-R-Mild	3	0
Pyuria-non-SAE-NR-Mild	0	1
Rales-non-SAE-NR-Mod	1	1
Rash-non-SAE-NR-Mild	2	1
Rash Generalised-non-SAE-R-Mild	0	1
Rectal Polyp-non-SAE-NR-Mod	1	0
Red Blood Cells Urine Positive-non-SAE-NR-Mild	1	0
Respiratory Tract Congestion-non-SAE-NR-Mild	2	0
Respiratory Tract Congestion-non-SAE-NR-Mod	1	0
Respiratory Tract Infection-non-SAE-NR-Mild	1	0
Respiratory Tract Infection-non-SAE-NR-Mod	1	0
Restless Legs Syndrome-non-SAE-NR-Mild	1	0
Rhinitis-non-SAE-NR-Mild	2	0
Rhinitis Perennial-non-SAE-NR-Mild	1	0
Rhinorrhoea-non-SAE-NR-Mild	2	1
Rhinorrhoea-non-SAE-R-Mild	0	1
Right Atrial Dilatation-non-SAE-NR-Mild	1	0
Rotator Cuff Syndrome-non-SAE-NR-Mild	1	0
Scab-non-SAE-NR-Mild	1	0
Scar-non-SAE-NR-Mild	1	0
Scoliosis-non-SAE-NR-Mild	0	1
Scratch-non-SAE-NR-Mild	1	0
Scrotal Swelling-non-SAE-R-Mild	3	0
Seborrhoeic Keratosis-non-SAE-NR-Mod	2	0
Sinus Congestion-non-SAE-NR-Mild	1	1
Sinus Headache-non-SAE-NR-Mild	2	0
Sinusitis-non-SAE-NR-Mild	34	3
Sinusitis-non-SAE-NR-Mod	29	13
Skin Hyperpigmentation-non-SAE-NR-Mild	1	0
Skin Lesion-non-SAE-NR-Mild	1	0
Skin Mass-non-SAE-NR-Mild	1	1
Sleep Apnoea Syndrome-non-SAE-NR-Mild	1	0
Slow Speech-non-SAE-NR-Mod	1	0
Solar Lentigo-non-SAE-NR-Mild	1	0
Somnolence-non-SAE-NR-Mild	1	0
Speech Disorder-non-SAE-NR-Mild	0	1
Spermatocele-non-SAE-NR-Mild	1	0
Spinal Compression Fracture-non-SAE-NR-Mod	1	0
Spinal Meningeal Cyst-SAE-NR-Sev	1	0
Spinal Osteoarthritis-non-SAE-NR-Mild	3	0
Squamous Cell Carcinoma-non-SAE-NR-Mod	4	2
Stress-non-SAE-NR-Mod	1	0
Suicide Attempt-non-SAE-NR-Sev	1	0
Sunburn-non-SAE-NR-Mild	1	0
Swelling Face-non-SAE-NR-Mod	1	0
Swelling Face-non-SAE-NR-Sev	0	1
Swollen Tongue-non-SAE-NR-Mild	1	0
Synovial Cyst-non-SAE-NR-Mild	1	0
Tachycardia-non-SAE-NR-Mild	5	1
Tachycardia-non-SAE-Mod	1	0
Tendon Disorder-non-SAE-NR-Sev	1	0
Tendonitis-non-SAE-NR-Mild	2	0
Tendonitis-non-SAE-NR-Mod	1	0
Testicular Microlithiasis-non-SAE-NR-Mild	1	0
Testicular Pain-non-SAE-NR-Mod	1	0
Thermal Burn-non-SAE-NR-Mild	0	1
Thinking Abnormal-non-SAE-NR-Mod	1	0
Thrombocytopenia-non-SAE-NR-Mild	1	0
Tibia Fracture-non-SAE-NR-Sev	1	0
Tinea Cruris-non-SAE-NR-Mild	1	0
Tinea Infection-non-SAE-NR-Mild	1	0
Tooth Abscess-non-SAE-NR-Mild	0	1
Tooth Abscess-non-SAE-NR-Mod	0	1
Tooth Fracture-non-SAE-NR-Mod	1	0
Tooth Infection-non-SAE-NR-Mild	1	0
Tooth Infection-non-SAE-NR-Mod	1	0
Toothache-non-SAE-NR-Mod	0	1
Toxicity To Various Agents-SAE-NR-Sev	1	0
Tracheal Stenosis-non-SAE-NR-Mild	0	1
Transient Ischaemic Attack-SAE-NR-Mod	0	1
Traumatic Haematoma-non-SAE-NR-Mild	1	0
Tricuspid Valve Incompetence-non-SAE-NR-Mild	1	0
Trigeminal Neuralgia-non-SAE-NR-Mild	1	0
Tympanic Membrane Scarring-non-SAE-NR-Mild	1	0
Type 2 Diabetes Mellitus-non-SAE-NR-Mod	2	0
Upper Limb Fracture-non-SAE-NR-Mod	1	0
Upper Limb Fracture-non-SAE-NR-Sev	1	0
Upper Respiratory Tract Infection-non-SAE-NR-Mild	16	8
Upper Respiratory Tract Infection-non-SAE-NR-Mod	13	2
Upper-Airway Cough Syndrome-non-SAE-NR-Mild	1	1
Urethritis-non-SAE-NR-Mild	1	0
Urinary Tract Infection-non-SAE-NR-Mild	4	4
Urinary Tract Infection-non-SAE-NR-Mod	6	2
Urticaria-non-SAE-NR-Mild	0	1
Urticaria-non-SAE-R-Mild	0	1
Uterine Polyp-non-SAE-NR-Mod	1	0
Vaginal Prolapse-SAE-NR-Mod	1	0
Vaginitis Bacterial-non-SAE-NR-Mild	2	0
Varicose Vein-non-SAE-NR-Mild	1	0
Vasomotor Rhinitis-non-SAE-NR-Mild	1	0
Vein Pain-non-SAE-NR-Mild	0	1
Ventricular Hypokinesia-non-SAE-NR-Mild	1	0
Vessel Puncture Site Bruise-non-SAE-NR-Mild	1	0
Viral Infection-non-SAE-NR-Mild	3	0
Viral Infection-non-SAE-NR-Mod	0	1
Viral Pharyngitis-non-SAE-NR-Mild	1	0
Viral Pharyngitis-non-SAE-NR-Mod	0	1
Viral Rash-non-SAE-NR-Mod	1	0
Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mild	29	5
Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mod	1	1
Vision Blurred-non-SAE-NR-Mild	1	0
Vitamin B12 Deficiency-non-SAE-NR-Mild	1	0
Vitamin D Decreased-non-SAE-NR-Mild	0	1
Vitamin D Deficiency-non-SAE-NR-Mild	2	0
Vitamin D Deficiency-non-SAE-NR-Mod	1	0
Vomiting-non-SAE-NR-Mild	13	2
Vomiting-non-SAE-NR-Mod	4	1
Vomiting-non-SAE-R-Mod	0	1
Vulvar Dysplasia-non-SAE-NR-Mild	2	0
Vulvovaginal Candidiasis-non-SAE-NR-Mild	1	0
Vulvovaginal Mycotic Infection-non-SAE-NR-Mild	4	1
Vulvovaginal Mycotic Infection-non-SAE-NR-Mod	2	0
Wheezing-non-SAE-NR-Mod	1	0
Wisdom Teeth Removal-non-SAE-NR-Mild	1	0
Wisdom Teeth Removal-non-SAE-NR-Sev	1	0
Wound-non-SAE-NR-Mild	0	1
Wrist Fracture-non-SAE-NR-Mod	0	1
Xeroderma-non-SAE-NR-Mild	1	0

14. Secondary Outcome

Title	Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).
Description	Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs per participant
Abdominal Distension-non-SAE-Mild	0.095	0
Abdominal Hernia-non-SAE-Mild	0.016	0
Abdominal Mass-non-SAE-Mild	0	0.020
Abdominal Pain-non-SAE-Mild	0.032	0.078
Abdominal Pain-non-SAE-Mod	0.063	0
Abdominal Pain-non-SAE-Severe	0.016	0
Abdominal Pain Upper-non-SAE-Mild	0.127	0
Abdominal Tenderness-non-SAE-Mild	0.048	0
Abnormal Loss of Weight-non-SAE-Mild	0.016	0
Acarodermatitis-non-SAE-Mild	0.032	0.020
Acarodermatitis-non-SAE-Mod	0.032	0
Acne-non-SAE-Mild	0.016	0
Acne-non-SAE-Mod	0.016	0
Actinic Keratosis-non-SAE-Mild	0.016	0
Actinic Keratosis-non-SAE-Mod	0.016	0.039
Activities of Daily Living Impaired-non-SAE-Mod	0.016	0
Acute Sinusitis-non-SAE-Mild	0	0.020
Acute Sinusitis-non-SAE-Mod	0.016	0
Acute Stress Disorder-non-SAE-Mild	0.016	0
Adhesiolysis-SAE-Mod	0.016	0
Age-Related Macular Degeneration-non-SAE-Mild	0.016	0
Agitation-non-SAE-Mild	0.016	0
Aldolase Increased-non-SAE-Mild	0.016	0
Anaphylactic Reaction-non-SAE-Sev	0	0.020
Animal Bite-non-SAE-Mild	0.016	0
Animal Scratch-non-SAE-Mild	0	0.020
Anxiety-non-SAE-Mild	0.032	0
Anxiety-non-SAE-Mod	0.032	0
Aortic Calcification-non-SAE-Mild	0.016	0
Aortic Stenosis-non-SAE-Mild	0.016	0
Aortic Stenosis-non-SAE-Mod	0.016	0
Aortic Valve Incompetence-non-SAE-Mod	0.016	0
Aortic Valve Incompetence-SAE-Sev	0.016	0
Aphthous Stomatitis-non-SAE-Mild	0.079	0.039
Aphthous Stomatitis-non-SAE-Mod	0.032	0
Appendicitis-SAE-Mod	0.016	0
Application Site Erythema-non-SAE-Mild	0.016	0
Arteritis-non-SAE-Mod	0.016	0
Arthralgia-non-SAE-Mild	0.127	0.020
Arthralgia-non-SAE-Mod	0	0.118
Arthropod Bite-non-SAE-Mild	0.016	0.020
Asthenia-non-SAE-Mild	0.111	0
Asthenia-non-SAE-Mod	0.143	0.020
Asthma-non-SAE-Mild	0.190	0.059
Asthma-non-SAE-Mod	0.317	0.059
Ataxia-non-SAE-Mild	0.032	0
Atelectasis-non-SAE-Mild	0.016	0
Atrial Fibrillation-non-SAE-Mild	0.016	0
Atrial Fibrillation-SAE-Mod	0.016	0
ADHD-non-SAE-Mod	0.016	0
Back Pain-non-SAE-Mild	0.048	0.039
Back Pain-non-SAE-Mod	0.048	0.039
Back Pain-non-SAE-Sev	0	0.020
Basal Cell Carcinoma-non-SAE-Mild	0.016	0
Basal Cell Carcinoma-non-SAE-Mod	0.063	0.020
Blepharochalasis-non-SAE-Mild	0.016	0
Blister-non-SAE-Mild	0.016	0
Blood Bicarbonate Decreased-non-SAE-Mild	0.016	0
Blood Creatine Phosphokinase Inc.-non-SAE-Mild	0.048	0
Blood Creatine Phosphokinase Inc.-non-SAE-Mod	0.032	0
Blood Creatinine Increased-non-SAE-Mild	0.016	0.020
Blood Glucose Increased-non-SAE-Mild	0.063	0.020
Blood Urea Increased-non-SAE-Mild	0	0.020
Blood Urine Present-non-SAE-Mild	0.032	0
Body Tinea-non-SAE-Mild	0.032	0
Bone Pain-non-SAE-Mild	0.016	0
Breast Calcifications-non-SAE-Mild	0.016	0
Breast Dysplasia-non-SAE-Mild	0	0.020
Bronchiolitis-non-SAE-Mild	0.016	0
Bronchitis-non-SAE-Mild	0.175	0.098
Bronchitis-non-SAE-Mod	0.175	0.039
Burns Second Degree-non-SAE-Mild	0.016	0
Bursitis-non-SAE-Mild	0.032	0
Candidiasis-non-SAE-Mild	0.016	0
Cardiac Failure Congestive-SAE-Mild	0.016	0
Cardiac Murmur-non-SAE-Mild	0.032	0
Cardiomegaly-non-SAE-Mild	0	0.020
Cardiomegaly-non-SAE-Mod	0.032	0
Cardiomyopathy-non-SAE-Mild	0.016	0
Cataract-non-SAE-Mild	0.016	0.020
Cataract-non-SAE-Mod	0.032	0
Cellulitis-non-SAE-Mild	0.032	0
Cellulitis-non-SAE-Mod	0.032	0.020
Cellulitis-SAE-Mod	0	0.020
Cellulitis Of Male Ext Genital Organ-non-SAE-Mod	0.016	0
Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild	0.016	0
Cerumen Impaction-non-SAE-Mild	0.032	0.039
Cervical Spinal Stenosis-non-SAE-Mild	0	0.020
Chapped Lips-non-SAE-Mild	0.016	0
Cheilitis-non-SAE-Mild	0.016	0
Chest Discomfort-non-SAE-Mild	0.016	0
Chest Pain-non-SAE-Mild	0.032	0
Chest Pain-non-SAE-Mod	0.016	0
Chills-non-SAE-Mild	0.206	0.020
Chills-non-SAE-Mod	0.016	0
Cholelithiasis-non-SAE-Mild	0.032	0
Chondromalacia-non-SAE-Mod	0.016	0
Chromaturia-non-SAE-Mild	0.016	0
COPD-non-SAE-Mild	0.032	0
COPD-non-SAE-Mod	0.048	0
COPD-SAE-Mod	0.016	0
COPD-SAE-Sev	0.016	0
Chronic Sinusitis-non-SAE-Mild	0.079	0.039
Chronic Sinusitis-non-SAE-Mod	0.048	0.020
Conjunctival Haemorrhage-non-SAE-Mild	0.016	0
Conjunctival Hyperaemia-non-SAE-Mild	0.032	0
Conjunctivitis-non-SAE-Mild	0	0.039
Conjunctivitis Allergic-non-SAE-Mild	0.016	0.020
Conjunctivitis Allergic-non-SAE-Mod	0	0.039
Conjunctivitis Infective-non-SAE-Mild	0.048	0.020
Constipation-non-SAE-Mild	0.048	0.059
Constipation-non-SAE-Mod	0.048	0
Contusion-non-SAE-Mild	0	0.059
Convulsion-non-SAE-Mild	0.016	0
Convulsion-non-SAE-Mod	0.032	0.020
Coombs Direct Test Positive-non-SAE-Mild	0.016	0
Coombs Test Positive-non-SAE-Mild	0.032	0
Corneal Abrasion-non-SAE-Mild	0.016	0
Costochondritis-non-SAE-Mild	0.016	0
Costochondritis-non-SAE-Sev	0.016	0
Cough-non-SAE-Mild	0.175	0.059
Cough-non-SAE-Mod	0.048	0.020
Cryptosporidiosis Infection-SAE-Sev	0.016	0
Cyst-non-SAE-Mild	0.016	0
Cyst-non-SAE-Mod	0.032	0
Cystitis-non-SAE-Mild	0.016	0
Cystocele-SAE-Mod	0.016	0
Decreased Appetite-non-SAE-Mild	0.063	0.157
Decreased Appetite-non-SAE-Mod	0.032	0
Dehydration-non-SAE-Mild	0.016	0
Dehydration-non-SAE-Mod	0.016	0
Dental Caries-non-SAE-Mild	0.032	0
Depression-non-SAE-Mild	0.016	0
Depression-non-SAE-Mod	0.048	0.020
Dermal Cyst-non-SAE-Mod	0.016	0
Dermatitis-non-SAE-Mild	0.016	0
Dermatitis Allergic-non-SAE-Mild	0	0.020
Dermatitis Atopic-non-SAE-Mild	0.016	0
Dermatitis Contact-non-SAE-Mild	0.048	0
Dermatitis Contact-non-SAE-Mod	0.016	0
Dermatitis Psoriasiform-non-SAE-Sev	0.016	0
Device Breakage-non-SAE-Mod	0.016	0
Device Failure-non-SAE-Mod	0.016	0
Diarrhoea-non-SAE-Mild	0.270	0.098
Diarrhoea-non-SAE-Mod	0.032	0
Dizziness-non-SAE-Mild	0.159	0.020
Dizziness-non-SAE-Mod	0.016	0
Drug Eruption-non-SAE-Mod	0	0.020
Drug Hypersensitivity-non-SAE-Mild	0.048	0
Dry Eye-non-SAE-Mild	0.016	0
Dry Eye-non-SAE-Mod	0.016	0.020
Dry Mouth-non-SAE-Mild	0	0.020
Dry Skin-non-SAE-Mild	0	0.020
Dysmenorrhoea-non-SAE-Mild	0.016	0
Dyspepsia-non-SAE-Mild	0	0.059
Dysplastic Naevus-non-SAE-Mod	0.016	0
Dyspnoea-non-SAE-Mild	0.032	0.020
Dyspnoea-non-SAE-Mod	0.032	0
Dysuria-non-SAE-Mild	0.016	0.020
Dysuria-non-SAE-Mod	0.032	0
Ear Infection-non-SAE-Mild	0.016	0
Ear Infection-non-SAE-Mod	0.048	0
Ear Pain-non-SAE-Mild	0.016	0
Ear Pain-non-SAE-Mod	0.032	0
Ear Pruritus-non-SAE-Mild	0	0.020
Ecchymosis-non-SAE-Mild	0.048	0
Ecchymosis-non-SAE-Mod	0	0.020
Eczema-non-SAE-Mild	0	0.039
Eczema-non-SAE-Mod	0.079	0
Empty Sella Syndrome-non-SAE-Mild	0.016	0
Epilepsy-non-SAE-Mod	0.016	0
Epistaxis-non-SAE-Mild	0.175	0.098
Erythema-non-SAE-Mild	0.016	0
Eschar-non-SAE-Mild	0.016	0
Excoriation-non-SAE-Mild	0.127	0.020
Excoriation-non-SAE-Mod	0.016	0
Eye Haemorrhage-non-SAE-Mild	0.016	0
Eye Infection-non-SAE-Mild	0.016	0.020
Eye Pain-non-SAE-Mild	0	0.020
Eye Swelling-non-SAE-Mild	0.016	0
Eyelid Ptosis-non-SAE-Mild	0.016	0
Facial Bones Fracture-non-SAE-Mod	0	0.020
Facial Pain-non-SAE-Mod	0.016	0
Fall-non-SAE-Mild	0.048	0.020
Fall-non-SAE-Sev	0	0.020
Fatigue-non-SAE-Mild	0.317	0.294
Fatigue-non-SAE-Mod	0.095	0.157
Fatigue-non-SAE-Sev	0.016	0
Femur Fracture-SAE-Sev	0	0.020
Fibromyalgia-non-SAE-Mod	0.032	0.020
Flatulence-non-SAE-Mod	0.016	0
Flushing-non-SAE-Mod	0	0.020
Folliculitis-non-SAE-Mild	0.016	0
Food Poisoning-non-SAE-Mild	0.032	0
Food Poisoning-non-SAE-Mod	0.016	0
Foot Fracture-non-SAE-Mod	0.016	0
Free Haemoglobin Present-non-SAE-Mild	0.032	0
Free Haemoglobin Present-non-SAE-Mod	0.032	0
Frequent Bowel Movements-non-SAE-Mod	0.016	0
Fungal Infection-non-SAE-Mild	0.016	0.020
Fungal Skin Infection-non-SAE-Mild	0.016	0

15. Secondary Outcome

Title	Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).
Description	Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs per participant
Gastric Stenosis-non-SAE-Mod	0.016	0
Gastritis-non-SAE-Mild	0.016	0
Gastroenteritis-non-SAE-Mild	0.048	0
Gastroenteritis-non-SAE-Mod	0.032	0
Gastroenteritis Salmonella-non-SAE-Mod	0.016	0
Gastroenteritis Viral-non-SAE-Mild	0.063	0.020
Gastroenteritis Viral-non-SAE-Mod	0.048	0.020
Gastrointestinal Viral Infection-non-SAE-Mild	0.016	0
Gastrooesophageal Reflux Disease-non-SAE-Mild	0.048	0
Gastrooesophageal Reflux Disease-non-SAE-Mod	0.016	0
Genital Herpes-non-SAE-Mild	0.032	0.039
Genital Herpes-non-SAE-Mod	0	0.020
Gingival Erosion-non-SAE-Mild	0.016	0
Gingivitis-non-SAE-Mild	0.016	0
Glaucoma-non-SAE-Mod	0.016	0
Glycosuria-non-SAE-Mild	0.016	0
Gout-non-SAE-Mod	0.016	0
Haematochezia-non-SAE-Mild	0.016	0
Haematospermia-non-SAE-Mild	0.016	0
Haematuria-non-SAE-Mild	0.016	0.020
Haemoglobin Decreased-non-SAE-Mild	0	0.020
Haemolysis-non-SAE-Mild	0.016	0
Haemorrhoids-non-SAE-Mild	0.032	0
Haemorrhoids-non-SAE-Mod	0.032	0
Hand Fracture-non-SAE-Mod	0.016	0
Headache-non-SAE-Mild	0.651	0.765
Headache-non-SAE-Mod	0.095	0.039
Heart Rate Irregular-non-SAE-Mild	0.032	0.020
Herpes Zoster-non-SAE-Mod	0.048	0
Hiatus Hernia-non-SAE-Mild	0.016	0
Hydrocele-non-SAE-Mild	0.016	0
Hypercapnia-non-SAE-Mild	0.016	0
Hypercholesterolaemia-non-SAE-Mild	0.016	0
Hypersensitivity-non-SAE-Mild	0.032	0
Hypertension-non-SAE-Mild	0.016	0.020
Hypertension-non-SAE-Mod	0.095	0
Hypertension-SAE-Mod	0.016	0
Hypoaesthesia-non-SAE-Mild	0.016	0
Hypokalaemia-non-SAE-Mild	0	0.039
Hypothyroidism-non-SAE-Mild	0	0.039
Hypothyroidism-non-SAE-Mod	0.016	0
Impetigo-non-SAE-Mild	0.032	0
Incision Site Pain-non-SAE-Mod	0.016	0
Increased Upper Airway Secretion-non-SAE-Mild	0.016	0
Inflammation Of Wound-non-SAE-Mild	0	0.020
Influenza-non-SAE-Mod	0.095	0.078
Influenza Like Illness-non-SAE-Mild	0.048	0
Influenza Like Illness-non-SAE-Mod	0.016	0
Infusion Site Abscess-non-SAE-Mild	0.016	0
Infusion Site Bruising-non-SAE-Mild	0.016	0
Infusion Site Discolouration-non-SAE-Mild	0.016	0
Infusion Site Discomfort-non-SAE-Mild	0.127	0.039
Infusion Site Erythema-non-SAE-Mild	0.349	0
Infusion Site Erythema-non-SAE-Mod	0.016	0
Infusion Site Induration-non-SAE-Mild	0.032	0
Infusion Site Mass-non-SAE-Mild	0.016	0
Infusion Site Oedema-non-SAE-Mild	0.016	0
Infusion Site Pain-non-SAE-Mild	1.238	0.333
Infusion Site Pain-non-SAE-Mod	0.095	0.039
Infusion Site Pruritus-non-SAE-Mild	0.492	0
Infusion Site Swelling-non-SAE-Mild	0.048	0
Infusion Site Swelling-non-SAE-Sev	0.016	0
Injection Site Pain-non-SAE-Mild	0.048	0
Insomnia-non-SAE-Mild	0.079	0
Insomnia-non-SAE-Mod	0	0.020
Intervertebral Disc Degeneration-non-SAE-Mild	0.016	0
Iron Deficiency Anaemia-non-SAE-Mild	0.016	0
Irritable Bowel Syndrome-non-SAE-Mod	0.032	0
Jejunal Stenosis-non-SAE-Mod	0.016	0
Joint Dislocation-non-SAE-Sev	0.016	0
Joint Injury-non-SAE-Mild	0.032	0
Joint Swelling-non-SAE-Mod	0	0.020
Laceration-non-SAE-Mild	0	0.020
Ligament Sprain-non-SAE-Mild	0.032	0
Ligament Sprain-non-SAE-Mod	0.016	0.039
Limb Discomfort-non-SAE-Mild	0	0.020
Liver Function Test Abnormal-non-SAE-Mild	0.016	0
Local Swelling-non-SAE-Mild	0.048	0
Localised Infection-non-SAE-Mod	0.016	0
Loss Of Consciousness-non-SAE-Mild	0	0.020
Lyme Disease-non-SAE-Mild	0.032	0
Lymph Gland Infection-non-SAE-Mod	0.016	0
Lymphadenitis-non-SAE-Mod	0	0.020
Lymphadenitis Bacterial-non-SAE-Mild	0.032	0
Lymphadenopathy-non-SAE-Mild	0.079	0.039
Lymphopenia-non-SAE-Mild	0.016	0
Malaise-non-SAE-Mild	0.048	0.020
Medical Device Pain-non-SAE-Mild	0.032	0
Memory Impairment-non-SAE-Mild	0.016	0
Meniscus Injury-non-SAE-Mild	0.016	0
Menstrual Disorder-non-SAE-Mod	0.016	0
Mental Status Changes-SAE-Sev	0.016	0
Micturition Urgency-non-SAE-Mild	0	0.020
Middle Ear Effusion-non-SAE-Mild	0	0.020
Migraine-non-SAE-Mild	0.063	0.039
Migraine-non-SAE-Mod	0.079	0.098
Migraine-non-SAE-Sev	0	0.020
Mitral Valve Incompetence-non-SAE-Mild	0.032	0
Molluscum Contagiosum-non-SAE-Mild	0.016	0.020
Mouth Ulceration-non-SAE-Mild	0	0.020
Mucosal Inflammation-non-SAE-Mild	0.016	0
Muscle Contractions Involuntary-non-SAE-Mild	0.016	0
Muscle Spasms-non-SAE-Mild	0.063	0
Muscle Strain-non-SAE-Mild	0.032	0
Muscular Weakness-non-SAE-Mild	0	0.020
Muscular Weakness-non-SAE-Mod	0.016	0
Musculoskeletal Pain-non-SAE-Mild	0.063	0
Musculoskeletal Pain-non-SAE-Mod	0.016	0.020
Myalgia-non-SAE-Mild	0.397	0.118
Myalgia-non-SAE-Mod	0.048	0.039

16. Secondary Outcome

Title	Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).
Description	Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs per participant
Nasal Congestion-non-SAE-Mild	0.175	0.098
Nasal Congestion-non-SAE-Mod	0.032	0
Nasal Discomfort-non-SAE-Mild	0.016	0
Nasopharyngitis-non-SAE-Mild	0.111	0.098
Nasopharyngitis-non-SAE-Mod	0.016	0
Nausea-non-SAE-Mild	0.619	0.333
Nausea-non-SAE-Mod	0.111	0.157
Nephrolithiasis-non-SAE-Mild	0	0.020
Nerve Compression-non-SAE-Mild	0	0.020
Neutrophil Count Decreased-non-SAE-Mild	0	0.020
Ocular Hyperaemia-non-SAE-Mild	0	0.020
Oedema Peripheral-non-SAE-Mild	0.063	0.098
Oedema Peripheral-non-SAE-Mod	0.063	0.020
Oral Candidiasis-non-SAE-Mild	0.032	0
Oral Herpes-non-SAE-Mild	0.111	0.039
Oral Pain-non-SAE-Mild	0	0.020
Oral Pain-non-SAE-Mod	0	0.020
Orchitis-non-SAE-Mod	0.016	0
Oropharyngeal Pain-non-SAE-Mild	0.063	0.020
Osteoarthritis-non-SAE-Mild	0.032	0.020
Osteoarthritis-non-SAE-Mod	0.016	0
Osteopenia-non-SAE-Mild	0.016	0
Osteoporosis-non-SAE-Mild	0	0.020
Otitis Externa-non-SAE-Mild	0.016	0.020
Otitis Externa-non-SAE-Mod	0	0.020
Otitis Media-non-SAE-Mod	0.016	0.020
Pain-non-SAE-Mild	0.143	0
Pain In Extremity-non-SAE-Mild	0.063	0.020
Pain In Extremity-non-SAE-Sev	0	0.020
Palpitations-non-SAE-Mild	0.032	0
Panic Attack-non-SAE-Mild	0	0.020
Papule-non-SAE-Mild	0.016	0
Paraesthesia-non-SAE-Mild	0.016	0
Paranasal Cyst-non-SAE-Mild	0.016	0
Pelvic Pain-non-SAE-Mod	0.016	0
Pericardial Effusion-non-SAE-Mild	0.016	0
Perineurial Cyst-non-SAE-Mod	0.016	0
Periodontal Disease-non-SAE-Mild	0.016	0
Pharyngitis-non-SAE-Mild	0.095	0.020
Pharyngitis-non-SAE-Mod	0	0.020
Pharyngitis Streptococcal-non-SAE-Mild	0.016	0
Pleural Effusion-non-SAE-Mild	0.016	0
Pleural Effusion-non-SAE-Mod	0.016	0
Pneumonia-non-SAE-Mild	0.016	0
Pneumonia Bacterial-non-SAE-Mod	0.016	0
Pneumonia Pseudomonas Aeruginosa-SAE-Sev	0.016	0
Pollakiuria-non-SAE-Mild	0	0.020
Pollakiuria-non-SAE-Mod	0.016	0
Polycystic Ovaries-non-SAE-Mild	0	0.020
Post Procedural Complication-non-SAE-Mod	0.016	0
Post Procedural Haemorrhage-non-SAE-Mild	0.016	0
Post Procedural Swelling-non-SAE-Mild	0.016	0
Procedural Nausea-non-SAE-Mod	0.016	0
Procedural Pain-non-SAE-Mild	0	0.020
Procedural Pain-non-SAE-Mod	0.143	0.020
Proctalgia-non-SAE-Mod	0.016	0
Productive Cough-non-SAE-Mild	0.032	0
Protein Urine Present-non-SAE-Mild	0.016	0
Pruritus-non-SAE-Mild	0.048	0.118
Pruritus-non-SAE-Mod	0.016	0
Pruritus Allergic-non-SAE-Mod	0	0.020
Pruritus Generalised-non-SAE-Mild	0	0.020
Pulmonary Hypertension-non-SAE-Mild	0.016	0
Pulmonary Hypertension-non-SAE-Mod	0.016	0
Pulmonary Vascular Disorder-non-SAE-Mod	0.016	0
Puncture Site Pain-non-SAE-Mild	0	0.020
Puncture Site Pain-non-SAE-Mod	0	0.039
Purpura Senile-non-SAE-Mild	0	0.020
Pyogenic Granuloma-non-SAE-Mod	0.016	0.020
Pyrexia-non-SAE-Mild	0.222	0.098
Pyrexia-non-SAE-Mod	0.032	0
Pyuria-non-SAE-Mild	0	0.020
Rales-non-SAE-Mod	0.016	0.020
Rash-non-SAE-Mild	0.032	0.020
Rash Generalised-non-SAE-Mild	0	0.020
Rectal Polyp-non-SAE-Mod	0.016	0
Red Blood Cells Urine Positive-non-SAE-Mild	0.016	0
Respiratory Tract Congestion-non-SAE-Mild	0.032	0
Respiratory Tract Congestion-non-SAE-Mod	0.016	0
Respiratory Tract Infection-non-SAE-Mild	0.016	0
Respiratory Tract Infection-non-SAE-Mod	0.016	0
Restless Legs Syndrome-non-SAE-Mild	0.016	0
Rhinitis-non-SAE-Mild	0.032	0
Rhinitis Perennial-non-SAE-Mild	0.016	0
Rhinorrhoea-non-SAE-Mild	0.032	0.039
Right Atrial Dilatation-non-SAE-Mild	0.016	0
Rotator Cuff Syndrome-non-SAE-Mild	0.016	0
Scab-non-SAE-Mild	0.016	0
Scar-non-SAE-Mild	0.016	0
Scoliosis-non-SAE-Mild	0	0.020
Scratch-non-SAE-Mild	0.016	0
Scrotal Swelling-non-SAE-Mild	0.048	0
Seborrhoeic Keratosis-non-SAE-Mod	0.032	0
Sinus Congestion-non-SAE-Mild	0.016	0.020
Sinus Headache-non-SAE-Mild	0.032	0
Sinusitis-non-SAE-Mild	0.540	0.059
Sinusitis-non-SAE-Mod	0.460	0.255
Skin Hyperpigmentation-non-SAE-Mild	0.016	0
Skin Lesion-non-SAE-Mild	0.016	0
Skin Mass-non-SAE-Mild	0.016	0.020
Sleep Apnoea Syndrome-non-SAE-Mild	0.016	0
Slow Speech-non-SAE-Mod	0.016	0
Solar Lentigo-non-SAE-Mild	0.016	0
Somnolence-non-SAE-Mild	0.016	0
Speech Disorder-non-SAE-Mild	0	0.020
Spermatocele-non-SAE-Mild	0.016	0
Spinal Compression Fracture-non-SAE-Mod	0.016	0
Spinal Meningeal Cyst-SAE-Sev	0.016	0
Spinal Osteoarthritis-non-SAE-Mild	0.048	0
Squamous Cell Carcinoma-non-SAE-Mod	0.063	0.039
Stress-non-SAE-Mod	0.016	0
Suicide Attempt-non-SAE-Sev	0.016	0
Sunburn-non-SAE-Mild	0.016	0
Swelling Face-non-SAE-Mod	0.016	0
Swelling Face-non-SAE-Sev	0	0.020
Swollen Tongue-non-SAE-Mild	0.016	0
Synovial Cyst-non-SAE-Mild	0.016	0
Tachycardia-non-SAE-Mild	0.079	0.020
Tachycardia-non-SAE-Mod	0.016	0
Tendon Disorder-non-SAE-Sev	0.016	0
Tendonitis-non-SAE-Mild	0.032	0
Tendonitis-non-SAE-Mod	0.016	0
Testicular Microlithiasis-non-SAE-Mild	0.016	0
Testicular Pain-non-SAE-Mod	0.016	0
Thermal Burn-non-SAE-Mild	0	0.020
Thinking Abnormal-non-SAE-Mod	0.016	0
Thrombocytopenia-non-SAE-Mild	0.016	0
Tibia Fracture-non-SAE-Sev	0.016	0
Tinea Cruris-non-SAE-Mild	0.016	0
Tinea Infection-non-SAE-Mild	0.016	0
Tooth Abscess-non-SAE-Mild	0	0.020
Tooth Abscess-non-SAE-Mod	0	0.020
Tooth Fracture-non-SAE-Mod	0.016	0
Tooth Infection-non-SAE-Mild	0.016	0
Tooth Infection-non-SAE-Mod	0.016	0
Toothache-non-SAE-Mod	0	0.020
Toxicity To Various Agents-SAE-Sev	0.016	0
Tracheal Stenosis-non-SAE-Mild	0	0.020
Transient Ischaemic Attack-SAE-Mod	0	0.020
Traumatic Haematoma-non-SAE-Mild	0.016	0
Tricuspid Valve Incompetence-non-SAE-Mild	0.016	0
Trigeminal Neuralgia-non-SAE-Mild	0.016	0
Tympanic Membrane Scarring-non-SAE-Mild	0.016	0
Type 2 Diabetes Mellitus-non-SAE-Mod	0.032	0
Upper Limb Fracture-non-SAE-Mod	0.016	0
Upper Limb Fracture-non-SAE-Sev	0.016	0
Upper Respiratory Tract Infection-non-SAE-Mild	0.254	0.157
Upper Respiratory Tract Infection-non-SAE-Mod	0.206	0.039
Upper-Airway Cough Syndrome-non-SAE-Mild	0.016	0.020
Urethritis-non-SAE-Mild	0.016	0
Urinary Tract Infection-non-SAE-Mild	0.063	0.078
Urinary Tract Infection-non-SAE-Mod	0.095	0.039
Urticaria-non-SAE-Mild	0	0.039
Uterine Polyp-non-SAE-Mod	0.016	0
Vaginal Prolapse-SAE-Mod	0.016	0
Vaginitis Bacterial-non-SAE-Mild	0.032	0
Varicose Vein-non-SAE-Mild	0.016	0
Vasomotor Rhinitis-non-SAE-Mild	0.016	0
Vein Pain-non-SAE-Mild	0	0.020
Ventricular Hypokinesia-non-SAE-Mild	0.016	0
Vessel Puncture Site Bruise-non-SAE-Mild	0.016	0
Viral Infection-non-SAE-Mild	0.048	0
Viral Infection-non-SAE-Mod	0	0.020
Viral Pharyngitis-non-SAE-Mild	0.016	0
Viral Pharyngitis-non-SAE-Mod	0	0.020
Viral Rash-non-SAE-Mod	0.016	0
Viral Upper Respiratory Tract Inf.-non-SAE-Mild	0.460	0.098
Viral Upper Respiratory Tract Inf-non-SAE-Mod	0.016	0.020
Vision Blurred-non-SAE-Mild	0.016	0
Vitamin B12 Deficiency-non-SAE-Mild	0.016	0
Vitamin D Decreased-non-SAE-Mild	0	0.020
Vitamin D Deficiency-non-SAE-Mild	0.032	0
Vitamin D Deficiency-non-SAE-Mod	0.016	0
Vomiting-non-SAE-Mild	0.206	0.039
Vomiting-non-SAE-Mod	0.063	0.039
Vulvar Dysplasia-non-SAE-Mild	0.032	0
Vulvovaginal Candidiasis-non-SAE-Mild	0.016	0
Vulvovaginal Mycotic Infection-non-SAE-Mild	0.063	0.020
Vulvovaginal Mycotic Infection-non-SAE-Mod	0.032	0
Wheezing-non-SAE-Mod	0.016	0
Wisdom Teeth Removal-non-SAE-Mild	0.016	0
Wisdom Teeth Removal-non-SAE-Sev	0.016	0
Wound-non-SAE-Mild	0	0.020
Wrist Fracture-non-SAE-Mod	0	0.020
Xeroderma-non-SAE-Mild	0.016	0

17. Secondary Outcome

Title	Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).
Description	Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Number of AEs per infusion
Abdominal Distension-non-SAE-Mild	0.004	0
Abdominal Hernia-non-SAE-Mild	0.001	0
Abdominal Mass-non-SAE-Mild	0.002	0
Abdominal Pain-non-SAE-Mild	0.001	0.007
Abdominal Pain-non-SAE-Mod	0.003	0
Abdominal Pain-non-SAE-Severe	0.001	0
Abdominal Pain Upper-non-SAE-Mild	0.005	0
Abdominal Tenderness-non-SAE-Mild	0.002	0
Abnormal Loss of Weight-non-SAE-Mild	0.001	0
Acarodermatitis-non-SAE-Mild	0.001	0.002
Acarodermatitis-non-SAE-Mod	0.001	0
Acne-non-SAE-Mild	0.001	0
Acne-non-SAE-Mod	0.001	0
Actinic Keratosis-non-SAE-Mild	0.001	0
Actinic Keratosis-non-SAE-Mod	0.001	0.003
Activities of Daily Living Impaired-non-SAE-Mod	0.001	0
Acute Sinusitis-non-SAE-Mild	0	0.002
Acute Sinusitis-non-SAE-Mod	0.001	0
Acute Stress Disorder-non-SAE-Mild	0.001	0
Adhesiolysis-SAE-Mod	0.001	0
Age-Related Macular Degeneration-non-SAE-Mild	0.001	0
Agitation-non-SAE-Mild	0.001	0
Aldolase Increased-non-SAE-Mild	0.001	0
Anaphylactic Reaction-non-SAE-Sev	0	0.002
Animal Bite-non-SAE-Mild	0.001	0
Animal Scratch-non-SAE-Mild	0	0.002
Anxiety-non-SAE-Mild	0.001	0
Anxiety-non-SAE-Mod	0.001	0
Aortic Calcification-non-SAE-Mild	0.001	0
Aortic Stenosis-non-SAE-Mild	0.001	0
Aortic Stenosis-non-SAE-Mod	0.001	0
Aortic Valve Incompetence-non-SAE-Mod	0.001	0
Aortic Valve Incompetence-SAE-Sev	0.001	0
Aphthous Stomatitis-non-SAE-Mild	0.003	0.003
Aphthous Stomatitis-non-SAE-Mod	0.001	0
Appendicitis-SAE-Mod	0.001	0
Application Site Erythema-non-SAE-Mild	0.001	0
Arteritis-non-SAE-Mod	0.001	0
Arthralgia-non-SAE-Mild	0.005	0.002
Arthralgia-non-SAE-Mod	0	0.010
Arthropod Bite-non-SAE-Mild	0.001	0.002
Asthenia-non-SAE-Mild	0.004	0
Asthenia-non-SAE-Mod	0.006	0.002
Asthma-non-SAE-Mild	0.008	0.005
Asthma-non-SAE-Mod	0.013	0.005
Ataxia-non-SAE-Mild	0.001	0
Atelectasis-non-SAE-Mild	0.001	0
Atrial Fibrillation-non-SAE-Mild	0.001	0
Atrial Fibrillation-SAE-Mod	0.001	0
ADHD-non-SAE-Mod	0.001	0
Back Pain-non-SAE-Mild	0.002	0.003
Back Pain-non-SAE-Mod	0.002	0.003
Back Pain-non-SAE-Sev	0	0.002
Basal Cell Carcinoma-non-SAE-Mild	0.001	0
Basal Cell Carcinoma-non-SAE-Mod	0.003	0.002
Blepharochalasis-non-SAE-Mild	0.001	0
Blister-non-SAE-Mild	0.001	0
Blood Bicarbonate Decreased-non-SAE-Mild	0.001	0
Blood Creatine Phosphokinase Inc.-non-SAE-Mild	0.002	0
Blood Creatine Phosphokinase Inc.-non-SAE-Mod	0.001	0
Blood Creatinine Increased-non-SAE-Mild	0.001	0.002
Blood Glucose Increased-non-SAE-Mild	0.003	0.002
Blood Urea Increased-non-SAE-Mild	0	0.002
Blood Urine Present-non-SAE-Mild	0.001	0
Body Tinea-non-SAE-Mild	0.001	0
Bone Pain-non-SAE-Mild	0.001	0
Breast Calcifications-non-SAE-Mild	0.001	0
Breast Dysplasia-non-SAE-Mild	0	0.002
Bronchiolitis-non-SAE-Mild	0.001	0
Bronchitis-non-SAE-Mild	0.007	0.008
Bronchitis-non-SAE-Mod	0.007	0.003
Burns Second Degree-non-SAE-Mild	0.001	0
Bursitis-non-SAE-Mild	0.001	0
Candidiasis-non-SAE-Mild	0.001	0
Cardiac Failure Congestive-SAE-Mild	0.001	0
Cardiac Murmur-non-SAE-Mild	0.001	0
Cardiomegaly-non-SAE-Mild	0	0.002
Cardiomegaly-non-SAE-Mod	0.001	0
Cardiomyopathy-non-SAE-Mild	0.001	0
Cataract-non-SAE-Mild	0.001	0.002
Cataract-non-SAE-Mod	0.001	0
Cellulitis-non-SAE-Mild	0.001	0
Cellulitis-non-SAE-Mod	0.001	0.002
Cellulitis-SAE-Mod	0	0.002
Cellulitis Of Male Ext Genital Organ-non-SAE-Mod	0.001	0
Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild	0.001	0
Cerumen Impaction-non-SAE-Mild	0.001	0.003
Cervical Spinal Stenosis-non-SAE-Mild	0	0.002
Chapped Lips-non-SAE-Mild	0.001	0
Cheilitis-non-SAE-Mild	0.001	0
Chest Discomfort-non-SAE-Mild	0.001	0
Chest Pain-non-SAE-Mild	0.001	0
Chest Pain-non-SAE-Mod	0.001	0
Chills-non-SAE-Mild	0.008	0.002
Chills-non-SAE-Mod	0.001	0
Cholelithiasis-non-SAE-Mild	0.001	0
Chondromalacia-non-SAE-Mod	0.001	0
Chromaturia-non-SAE-Mild	0.001	0
COPD-non-SAE-Mild	0.001	0
COPD-non-SAE-Mod	0.002	0
COPD-SAE-Mod	0.001	0
COPD-SAE-Sev	0.001	0
Chronic Sinusitis-non-SAE-Mild	0.003	0.003
Chronic Sinusitis-non-SAE-Mod	0.002	0.002
Conjunctival Haemorrhage-non-SAE-Mild	0.001	0
Conjunctival Hyperaemia-non-SAE-Mild	0.001	0
Conjunctivitis-non-SAE-Mild	0	0.003
Conjunctivitis Allergic-non-SAE-Mild	0.001	0.002
Conjunctivitis Allergic-non-SAE-Mod	0	0.003
Conjunctivitis Infective-non-SAE-Mild	0.002	0.002
Constipation-non-SAE-Mild	0.002	0.005
Constipation-non-SAE-Mod	0.002	0
Contusion-non-SAE-Mild	0	0.005
Convulsion-non-SAE-Mild	0.001	0
Convulsion-non-SAE-Mod	0.001	0.002
Coombs Direct Test Positive-non-SAE-Mild	0.001	0
Coombs Test Positive-non-SAE-Mild	0.001	0
Corneal Abrasion-non-SAE-Mild	0.001	0
Costochondritis-non-SAE-Mild	0.001	0
Costochondritis-non-SAE-Sev	0.001	0
Cough-non-SAE-Mild	0.007	0.005
Cough-non-SAE-Mod	0.002	0.002
Cryptosporidiosis Infection-SAE-Sev	0.001	0
Cyst-non-SAE-Mild	0.001	0
Cyst-non-SAE-Mod	0.001	0
Cystitis-non-SAE-Mild	0.001	0
Cystocele-SAE-Mod	0.001	0
Decreased Appetite-non-SAE-Mild	0.003	0.013
Decreased Appetite-non-SAE-Mod	0.001	0
Dehydration-non-SAE-Mild	0.001	0
Dehydration-non-SAE-Mod	0.001	0
Dental Caries-non-SAE-Mild	0.001	0
Depression-non-SAE-Mild	0.001	0
Depression-non-SAE-Mod	0.002	0.002
Dermal Cyst-non-SAE-Mod	0.001	0
Dermatitis-non-SAE-Mild	0.001	0
Dermatitis Allergic-non-SAE-Mild	0	0.002
Dermatitis Atopic-non-SAE-Mild	0.001	0
Dermatitis Contact-non-SAE-Mild	0.002	0
Dermatitis Contact-non-SAE-Mod	0.001	0
Dermatitis Psoriasiform-non-SAE-Sev	0.001	0
Device Breakage-non-SAE-Mod	0.001	0
Device Failure-non-SAE-Mod	0.001	0
Diarrhoea-non-SAE-Mild	0.011	0.008
Diarrhoea-non-SAE-Mod	0.001	0
Dizziness-non-SAE-Mild	0.006	0.002
Dizziness-non-SAE-Mod	0.001	0
Drug Eruption-non-SAE-Mod	0	0.002
Drug Hypersensitivity-non-SAE-Mild	0.002	0
Dry Eye-non-SAE-Mild	0.001	0
Dry Eye-non-SAE-Mod	0.001	0.002
Dry Mouth-non-SAE-Mild	0	0.002
Dry Skin-non-SAE-Mild	0	0.002
Dysmenorrhoea-non-SAE-Mild	0.001	0
Dyspepsia-non-SAE-Mild	0	0.005
Dysplastic Naevus-non-SAE-Mod	0.001	0
Dyspnoea-non-SAE-Mild	0.001	0.002
Dyspnoea-non-SAE-Mod	0.001	0
Dysuria-non-SAE-Mild	0.001	0.002
Dysuria-non-SAE-Mod	0.001	0
Ear Infection-non-SAE-Mild	0.001	0
Ear Infection-non-SAE-Mod	0.002	0
Ear Pain-non-SAE-Mild	0.001	0
Ear Pain-non-SAE-Mod	0.001	0
Ear Pruritus-non-SAE-Mild	0	0.002
Ecchymosis-non-SAE-Mild	0.002	0
Ecchymosis-non-SAE-Mod	0	0.002
Eczema-non-SAE-Mild	0	0.003
Eczema-non-SAE-Mod	0.003	0
Empty Sella Syndrome-non-SAE-Mild	0.001	0
Epilepsy-non-SAE-Mod	0.001	0
Epistaxis-non-SAE-Mild	0.007	0.008
Erythema-non-SAE-Mild	0.001	0
Eschar-non-SAE-Mild	0.001	0
Excoriation-non-SAE-Mild	0.005	0.002
Excoriation-non-SAE-Mod	0.001	0
Eye Haemorrhage-non-SAE-Mild	0.001	0
Eye Infection-non-SAE-Mild	0.001	0.002
Eye Pain-non-SAE-Mild	0	0.002
Eye Swelling-non-SAE-Mild	0.001	0
Eyelid Ptosis-non-SAE-Mild	0.001	0
Facial Bones Fracture-non-SAE-Mod	0	0.002
Facial Pain-non-SAE-Mod	0.001	0
Fall-non-SAE-Mild	0.002	0.002
Fall-non-SAE-Sev	0	0.002
Fatigue-non-SAE-Mild	0.013	0.025
Fatigue-non-SAE-Mod	0.004	0.013
Fatigue-non-SAE-Sev	0.001	0
Femur Fracture-SAE-Sev	0	0.002
Fibromyalgia-non-SAE-Mod	0.001	0.002
Flatulence-non-SAE-Mod	0.001	0
Flushing-non-SAE-Mod	0	0.002
Folliculitis-non-SAE-Mild	0.001	0
Food Poisoning-non-SAE-Mild	0.001	0
Food Poisoning-non-SAE-Mod	0.001	0
Foot Fracture-non-SAE-Mod	0.001	0
Free Haemoglobin Present-non-SAE-Mild	0.001	0
Free Haemoglobin Present-non-SAE-Mod	0.001	0
Frequent Bowel Movements-non-SAE-Mod	0.001	0
Fungal Infection-non-SAE-Mild	0.001	0.002
Fungal Skin Infection-non-SAE-Mild	0.001	0

18. Secondary Outcome

Title	Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).
Description	Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Number of AEs per infusion
Gastric Stenosis-non-SAE-Mod	0.001	0
Gastritis-non-SAE-Mild	0.001	0
Gastroenteritis-non-SAE-Mild	0.002	0
Gastroenteritis-non-SAE-Mod	0.001	0
Gastroenteritis Salmonella-non-SAE-Mod	0.001	0
Gastroenteritis Viral-non-SAE-Mild	0.003	0.002
Gastroenteritis Viral-non-SAE-Mod	0.002	0.002
Gastrointestinal Viral Infection-non-SAE-Mild	0.001	0
Gastrooesophageal Reflux Disease-non-SAE-Mild	0.002	0
Gastrooesophageal Reflux Disease-non-SAE-Mod	0.001	0
Genital Herpes-non-SAE-Mild	0.001	0.003
Genital Herpes-non-SAE-Mod	0	0.002
Gingival Erosion-non-SAE-Mild	0.001	0
Gingivitis-non-SAE-Mild	0.001	0
Glaucoma-non-SAE-Mod	0.001	0
Glycosuria-non-SAE-Mild	0.001	0
Gout-non-SAE-Mod	0.001	0
Haematochezia-non-SAE-Mild	0.001	0
Haematospermia-non-SAE-Mild	0.001	0
Haematuria-non-SAE-Mild	0.001	0.002
Haemoglobin Decreased-non-SAE-Mild	0	0.002
Haemolysis-non-SAE-Mild	0.001	0
Haemorrhoids-non-SAE-Mild	0.001	0
Haemorrhoids-non-SAE-Mod	0.001	0
Hand Fracture-non-SAE-Mod	0.001	0
Headache-non-SAE-Mild	0.026	0.065
Headache-non-SAE-Mod	0.004	0.003
Heart Rate Irregular-non-SAE-Mild	0.001	0.002
Herpes Zoster-non-SAE-Mod	0.002	0
Hiatus Hernia-non-SAE-Mild	0.001	0
Hydrocele-non-SAE-Mild	0.001	0
Hypercapnia-non-SAE-Mild	0.001	0
Hypercholesterolaemia-non-SAE-Mild	0.001	0
Hypersensitivity-non-SAE-Mild	0.001	0
Hypertension-non-SAE-Mild	0.001	0.002
Hypertension-non-SAE-Mod	0.004	0
Hypertension-SAE-Mod	0.001	0
Hypoaesthesia-non-SAE-Mild	0.001	0
Hypokalaemia-non-SAE-Mild	0	0.003
Hypothyroidism-non-SAE-Mild	0	0.003
Hypothyroidism-non-SAE-Mod	0.001	0
Impetigo-non-SAE-Mild	0.001	0
Incision Site Pain-non-SAE-Mod	0.001	0
Increased Upper Airway Secretion-non-SAE-Mild	0.001	0
Inflammation Of Wound-non-SAE-Mild	0	0.002
Influenza-non-SAE-Mod	0.004	0.007
Influenza Like Illness-non-SAE-Mild	0.002	0
Influenza Like Illness-non-SAE-Mod	0.001	0
Infusion Site Abscess-non-SAE-Mild	0.001	0
Infusion Site Bruising-non-SAE-Mild	0.001	0
Infusion Site Discolouration-non-SAE-Mild	0.001	0
Infusion Site Discomfort-non-SAE-Mild	0.005	0.003
Infusion Site Erythema-non-SAE-Mild	0.014	0
Infusion Site Erythema-non-SAE-Mod	0.001	0
Infusion Site Induration-non-SAE-Mild	0.001	0
Infusion Site Mass-non-SAE-Mild	0.001	0
Infusion Site Oedema-non-SAE-Mild	0.001	0
Infusion Site Pain-non-SAE-Mild	0.049	0.028
Infusion Site Pain-non-SAE-Mod	0.004	0.003
Infusion Site Pruritus-non-SAE-Mild	0.019	0
Infusion Site Swelling-non-SAE-Mild	0.002	0
Infusion Site Swelling-non-SAE-Sev	0.001	0
Injection Site Pain-non-SAE-Mild	0.002	0
Insomnia-non-SAE-Mild	0.003	0
Insomnia-non-SAE-Mod	0	0.002
Intervertebral Disc Degeneration-non-SAE-Mild	0.001	0
Iron Deficiency Anaemia-non-SAE-Mild	0.001	0
Irritable Bowel Syndrome-non-SAE-Mod	0.001	0
Jejunal Stenosis-non-SAE-Mod	0.001	0
Joint Dislocation-non-SAE-Sev	0.001	0
Joint Injury-non-SAE-Mild	0.001	0
Joint Swelling-non-SAE-Mod	0	0.002
Laceration-non-SAE-Mild	0	0.002
Ligament Sprain-non-SAE-Mild	0.001	0
Ligament Sprain-non-SAE-Mod	0.001	0.003
Limb Discomfort-non-SAE-Mild	0	0.002
Liver Function Test Abnormal-non-SAE-Mild	0.001	0
Local Swelling-non-SAE-Mild	0.002	0
Localised Infection-non-SAE-Mod	0.001	0
Loss Of Consciousness-non-SAE-Mild	0	0.002
Lyme Disease-non-SAE-Mild	0.001	0
Lymph Gland Infection-non-SAE-Mod	0.001	0
Lymphadenitis-non-SAE-Mod	0	0.002
Lymphadenitis Bacterial-non-SAE-Mild	0.001	0
Lymphadenopathy-non-SAE-Mild	0.003	0.003
Lymphopenia-non-SAE-Mild	0.001	0
Malaise-non-SAE-Mild	0.002	0.002
Medical Device Pain-non-SAE-Mild	0.001	0
Memory Impairment-non-SAE-Mild	0.001	0
Meniscus Injury-non-SAE-Mild	0.001	0
Menstrual Disorder-non-SAE-Mod	0.001	0
Mental Status Changes-SAE-Sev	0.001	0
Micturition Urgency-non-SAE-Mild	0	0.002
Middle Ear Effusion-non-SAE-Mild	0	0.002
Migraine-non-SAE-Mild	0.003	0.003
Migraine-non-SAE-Mod	0.003	0.008
Migraine-non-SAE-Sev	0	0.002
Mitral Valve Incompetence-non-SAE-Mild	0.001	0
Molluscum Contagiosum-non-SAE-Mild	0.001	0.002
Mouth Ulceration-non-SAE-Mild	0	0.002
Mucosal Inflammation-non-SAE-Mild	0.001	0
Muscle Contractions Involuntary-non-SAE-Mild	0.001	0
Muscle Spasms-non-SAE-Mild	0.003	0
Muscle Strain-non-SAE-Mild	0.001	0
Muscular Weakness-non-SAE-Mild	0	0.002
Muscular Weakness-non-SAE-Mod	0.001	0
Musculoskeletal Pain-non-SAE-Mild	0.003	0
Musculoskeletal Pain-non-SAE-Mod	0.001	0.002
Myalgia-non-SAE-Mild	0.016	0.010
Myalgia-non-SAE-Mod	0.002	0.003

19. Secondary Outcome

Title	Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).
Description	Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Number of AEs per infusion
Nasal Congestion-non-SAE-Mild	0.007	0.008
Nasal Congestion-non-SAE-Mod	0.001	0
Nasal Discomfort-non-SAE-Mild	0.001	0
Nasopharyngitis-non-SAE-Mild	0.004	0.008
Nasopharyngitis-non-SAE-Mod	0.001	0
Nausea-non-SAE-Mild	0.024	0.028
Nausea-non-SAE-Mod	0.004	0.013
Nephrolithiasis-non-SAE-Mild	0	0.002
Nerve Compression-non-SAE-Mild	0	0.002
Neutrophil Count Decreased-non-SAE-Mild	0	0.002
Ocular Hyperaemia-non-SAE-Mild	0	0.002
Oedema Peripheral-non-SAE-Mild	0.003	0.008
Oedema Peripheral-non-SAE-Mod	0.003	0.002
Oral Candidiasis-non-SAE-Mild	0.001	0
Oral Herpes-non-SAE-Mild	0.004	0.003
Oral Pain-non-SAE-Mild	0	0.002
Oral Pain-non-SAE-Mod	0	0.002
Orchitis-non-SAE-Mod	0.001	0
Oropharyngeal Pain-non-SAE-Mild	0.003	0.002
Osteoarthritis-non-SAE-Mild	0.001	0.002
Osteoarthritis-non-SAE-Mod	0.001	0
Osteopenia-non-SAE-Mild	0.001	0
Osteoporosis-non-SAE-Mild	0	0.002
Otitis Externa-non-SAE-Mild	0.001	0.002
Otitis Externa-non-SAE-Mod	0	0.002
Otitis Media-non-SAE-Mod	0.001	0.002
Pain-non-SAE-Mild	0.006	0
Pain In Extremity-non-SAE-Mild	0.003	0.002
Pain In Extremity-non-SAE-Sev	0	0.002
Palpitations-non-SAE-Mild	0.001	0
Panic Attack-non-SAE-Mild	0	0.002
Papule-non-SAE-Mild	0.001	0
Paraesthesia-non-SAE-Mild	0.001	0
Paranasal Cyst-non-SAE-Mild	0.001	0
Pelvic Pain-non-SAE-Mod	0.001	0
Pericardial Effusion-non-SAE-Mild	0.001	0
Perineurial Cyst-non-SAE-Mod	0.001	0
Periodontal Disease-non-SAE-Mild	0.001	0
Pharyngitis-non-SAE-Mild	0.004	0.002
Pharyngitis-non-SAE-Mod	0	0.002
Pharyngitis Streptococcal-non-SAE-Mild	0.001	0
Pleural Effusion-non-SAE-Mild	0.001	0
Pleural Effusion-non-SAE-Mod	0.001	0
Pneumonia-non-SAE-Mild	0.001	0
Pneumonia Bacterial-non-SAE-Mod	0.001	0
Pneumonia Pseudomonas Aeruginosa-SAE-Sev	0.001	0
Pollakiuria-non-SAE-Mild	0	0.002
Pollakiuria-non-SAE-Mod	0.001	0
Polycystic Ovaries-non-SAE-Mild	0	0.002
Post Procedural Complication-non-SAE-Mod	0.001	0
Post Procedural Haemorrhage-non-SAE-Mild	0.001	0
Post Procedural Swelling-non-SAE-Mild	0.001	0
Procedural Nausea-non-SAE-Mod	0.001	0
Procedural Pain-non-SAE-Mild	0	0.002
Procedural Pain-non-SAE-Mod	0.006	0.002
Proctalgia-non-SAE-Mod	0.001	0
Productive Cough-non-SAE-Mild	0.001	0
Protein Urine Present-non-SAE-Mild	0.001	0
Pruritus-non-SAE-Mild	0.002	0.010
Pruritus-non-SAE-Mod	0.001	0
Pruritus Allergic-non-SAE-Mod	0	0.002
Pruritus Generalised-non-SAE-Mild	0	0.002
Pulmonary Hypertension-non-SAE-Mild	0.001	0
Pulmonary Hypertension-non-SAE-Mod	0.001	0
Pulmonary Vascular Disorder-non-SAE-Mod	0.001	0
Puncture Site Pain-non-SAE-Mild	0	0.002
Puncture Site Pain-non-SAE-Mod	0	0.003
Purpura Senile-non-SAE-Mild	0	0.002
Pyogenic Granuloma-non-SAE-Mod	0.001	0.002
Pyrexia-non-SAE-Mild	0.009	0.008
Pyrexia-non-SAE-Mod	0.001	0
Pyuria-non-SAE-Mild	0	0.002
Rales-non-SAE-Mod	0.001	0.002
Rash-non-SAE-Mild	0.001	0.002
Rash Generalised-non-SAE-Mild	0	0.002
Rectal Polyp-non-SAE-Mod	0.001	0
Red Blood Cells Urine Positive-non-SAE-Mild	0.001	0
Respiratory Tract Congestion-non-SAE-Mild	0.001	0
Respiratory Tract Congestion-non-SAE-Mod	0.001	0
Respiratory Tract Infection-non-SAE-Mild	0.001	0
Respiratory Tract Infection-non-SAE-Mod	0.001	0
Restless Legs Syndrome-non-SAE-Mild	0.001	0
Rhinitis-non-SAE-Mild	0.001	0
Rhinitis Perennial-non-SAE-Mild	0.001	0
Rhinorrhoea-non-SAE-Mild	0.001	0.003
Right Atrial Dilatation-non-SAE-Mild	0.001	0
Rotator Cuff Syndrome-non-SAE-Mild	0.001	0
Scab-non-SAE-Mild	0.001	0
Scar-non-SAE-Mild	0.001	0
Scoliosis-non-SAE-Mild	0	0.002
Scratch-non-SAE-Mild	0.001	0
Scrotal Swelling-non-SAE-Mild	0.002	0
Seborrhoeic Keratosis-non-SAE-Mod	0.001	0
Sinus Congestion-non-SAE-Mild	0.001	0.002
Sinus Headache-non-SAE-Mild	0.001	0
Sinusitis-non-SAE-Mild	0.021	0.005
Sinusitis-non-SAE-Mod	0.018	0.022
Skin Hyperpigmentation-non-SAE-Mild	0.001	0
Skin Lesion-non-SAE-Mild	0.001	0
Skin Mass-non-SAE-Mild	0.001	0.002
Sleep Apnoea Syndrome-non-SAE-Mild	0.001	0
Slow Speech-non-SAE-Mod	0.001	0
Solar Lentigo-non-SAE-Mild	0.001	0
Somnolence-non-SAE-Mild	0.001	0
Speech Disorder-non-SAE-Mild	0	0.002
Spermatocele-non-SAE-Mild	0.001	0
Spinal Compression Fracture-non-SAE-Mod	0.001	0
Spinal Meningeal Cyst-SAE-Sev	0.001	0
Spinal Osteoarthritis-non-SAE-Mild	0.002	0
Squamous Cell Carcinoma-non-SAE-Mod	0.003	0.003
Stress-non-SAE-Mod	0.001	0
Suicide Attempt-non-SAE-Sev	0.001	0
Sunburn-non-SAE-Mild	0.001	0
Swelling Face-non-SAE-Mod	0.001	0
Swelling Face-non-SAE-Sev	0	0.002
Swollen Tongue-non-SAE-Mild	0.001	0
Synovial Cyst-non-SAE-Mild	0.001	0
Tachycardia-non-SAE-Mild	0.003	0.002
Tachycardia-non-SAE-Mod	0.001	0
Tendon Disorder-non-SAE-Sev	0.001	0
Tendonitis-non-SAE-Mild	0.001	0
Tendonitis-non-SAE-Mod	0.001	0
Testicular Microlithiasis-non-SAE-Mild	0.001	0
Testicular Pain-non-SAE-Mod	0.001	0
Thermal Burn-non-SAE-Mild	0	0.002
Thinking Abnormal-non-SAE-Mod	0.001	0
Thrombocytopenia-non-SAE-Mild	0.001	0
Tibia Fracture-non-SAE-Sev	0.001	0
Tinea Cruris-non-SAE-Mild	0.001	0
Tinea Infection-non-SAE-Mild	0.001	0
Tooth Abscess-non-SAE-Mild	0	0.002
Tooth Abscess-non-SAE-Mod	0	0.002
Tooth Fracture-non-SAE-Mod	0.001	0
Tooth Infection-non-SAE-Mild	0.001	0
Tooth Infection-non-SAE-Mod	0.001	0
Toothache-non-SAE-Mod	0	0.002
Toxicity To Various Agents-SAE-Sev	0.001	0
Tracheal Stenosis-non-SAE-Mild	0	0.002
Transient Ischaemic Attack-SAE-Mod	0	0.002
Traumatic Haematoma-non-SAE-Mild	0.001	0
Tricuspid Valve Incompetence-non-SAE-Mild	0.001	0
Trigeminal Neuralgia-non-SAE-Mild	0.001	0
Tympanic Membrane Scarring-non-SAE-Mild	0.001	0
Type 2 Diabetes Mellitus-non-SAE-Mod	0.001	0
Upper Limb Fracture-non-SAE-Mod	0.001	0
Upper Limb Fracture-non-SAE-Sev	0.001	0
Upper Respiratory Tract Infection-non-SAE-Mild	0.010	0.013
Upper Respiratory Tract Infection-non-SAE-Mod	0.008	0.003
Upper-Airway Cough Syndrome-non-SAE-Mild	0.001	0.002
Urethritis-non-SAE-Mild	0.001	0
Urinary Tract Infection-non-SAE-Mild	0.003	0.007
Urinary Tract Infection-non-SAE-Mod	0.004	0.003
Urticaria-non-SAE-Mild	0	0.003
Uterine Polyp-non-SAE-Mod	0.001	0
Vaginal Prolapse-SAE-Mod	0.001	0
Vaginitis Bacterial-non-SAE-Mild	0.001	0
Varicose Vein-non-SAE-Mild	0.001	0
Vasomotor Rhinitis-non-SAE-Mild	0.001	0
Vein Pain-non-SAE-Mild	0	0.002
Ventricular Hypokinesia-non-SAE-Mild	0.001	0
Vessel Puncture Site Bruise-non-SAE-Mild	0.001	0
Viral Infection-non-SAE-Mild	0.002	0
Viral Infection-non-SAE-Mod	0	0.002
Viral Pharyngitis-non-SAE-Mild	0.001	0
Viral Pharyngitis-non-SAE-Mod	0	0.002
Viral Rash-non-SAE-Mod	0.001	0
Viral Upper Respiratory Tract Inf.-non-SAE-Mild	0.018	0.008
Viral Upper Respiratory Tract Inf-non-SAE-Mod	0.001	0.002
Vision Blurred-non-SAE-Mild	0.001	0
Vitamin B12 Deficiency-non-SAE-Mild	0.001	0
Vitamin D Decreased-non-SAE-Mild	0	0.002
Vitamin D Deficiency-non-SAE-Mild	0.001	0
Vitamin D Deficiency-non-SAE-Mod	0.001	0
Vomiting-non-SAE-Mild	0.008	0.003
Vomiting-non-SAE-Mod	0.003	0.003
Vulvar Dysplasia-non-SAE-Mild	0.001	0
Vulvovaginal Candidiasis-non-SAE-Mild	0.001	0
Vulvovaginal Mycotic Infection-non-SAE-Mild	0.003	0.002
Vulvovaginal Mycotic Infection-non-SAE-Mod	0.001	0
Wheezing-non-SAE-Mod	0.001	0
Wisdom Teeth Removal-non-SAE-Mild	0.001	0
Wisdom Teeth Removal-non-SAE-Sev	0.001	0
Wound-non-SAE-Mild	0	0.002
Wrist Fracture-non-SAE-Mod	0	0.002
Xeroderma-non-SAE-Mild	0.001	0

20. Secondary Outcome

Title	Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study ("Related")
Description	Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs per participant
Total AEs, Mild	4.635	2.137
Total AEs, Moderate	0.476	0.392
Total AEs, Severe	0.016	0.059
Total AEs, Total	5.127	2.588
Local nsAEs, Mild	2.476	0.373
Local AEs, Moderate	0.111	0
Local AEs, Severe	0.016	0
Local AEs, Total	2.603	0.373
Systemic AEs including infections, Mild	2.159	1.765
Systemic AEs including infections, Moderate	0.365	0.392
Systemic AEs including infections, Severe	0	0.059
Systemic AEs including infections, Total	2.524	2.216
Systemic AEs excluding infections, Mild	2.159	1.765
Systemic AEs excluding infections, Moderate	0.365	0.392
Systemic AEs excluding infections, Severe	0	0.059
Systemic AEs excluding infections, Total	2.524	2.216

21. Secondary Outcome

Title	Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study ("Related")
Description	Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Number of AEs per infusion
Total AEs, Mild	0.183	0.182
Total AEs, Moderate	0.019	0.033
Total AEs, Severe	0.001	0.005
Total AEs, Total	0.202	0.221
Local AEs, Mild	0.098	0.032
Local AEs, Moderate	0.004	0
Local AEs, Severe	0.001	0
Local AEs, Total	0.103	0.032
Systemic AEs including infections, Mild	0.085	0.151
Systemic AEs including infections, Moderate	0.014	0.033
Systemic AEs including infections, Severe	0	0.005
Systemic AEs including infections, Total	0.099	0.189
Systemic AEs excluding infections, Mild	0.085	0.151
Systemic AEs excluding infections, Moderate	0.014	0.033
Systemic AEs excluding infections, Severe	0	0.005
Systemic AEs excluding infections, Total	0.099	0.189

22. Secondary Outcome

Title	Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion
Description	Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Measure Type: Number; Unit of Measure: Number of AEs per participant
Total, nsAE, Mild	5.921	2.275
Total, nsAE, Moderate	1.111	0.647
Total, nsAE, Severe	0.032	0.059
Total nsAE, Total	7.063	2.980
Total, SAE, Moderate	0.016	0
Total, SAE, Severe	0.016	0
Total, SAE, Total	0.032	0
Local, nsAE, Mild	2.492	0.353
Local, nsAE, Moderate	0.111	0.039
Local, nsAE, Severe	0.016	0
Local, nsAE, Total	2.619	0.392
Systemic including infections, nsAE, Mild	3.429	1.922
Systemic including infections, nsAE, Moderate	1.000	0.608
Systemic including infections, nsAE, Severe	0.016	0.059
Systemic including infections, nsAE, Total	4.444	2.588
Systemic including infections, SAE, Moderate	0.016	0
Systemic including infections, SAE, Severe	0.016	0
Systemic including infections, SAE, Total	0.032	0
Systemic excluding infections, nsAE, Mild	3.111	1.922
Systemic excluding infections, nsAE, Moderate	0.873	0.608
Systemic excluding infections, nsAE, Severe	0.016	0.059
Systemic excluding infections, nsAE, Total	4.000	2.588
Systemic excluding infections, SAE, Moderate	0.016	0
Systemic excluding infections, SAE, Severe	0.016	0
Systemic excluding infections, SAE, Total	0.032	0

23. Secondary Outcome

Title	Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion
Description	Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Data Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	63	51
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Number of AEs per infusion
Total, non-SAE, Mild	0.233	0.194
Total, non-SAE, Moderate	0.044	0.055
Total, non-SAE, Severe	0.001	0.005
Total non-SAE, Total	0.278	0.254
Total, SAE, Moderate	0.001	0
Total, SAE, Severe	0.001	0
Total, SAE, Total	0.001	0
Local, non-SAE, Mild	0.098	0.030
Local, non-SAE, Moderate	0.004	0.003
Local, non-SAE, Severe	0.001	0
Local, non-SAE, Total	0.103	0.033
Systemic including infections, non-SAE, Mild	0.135	0.164
Systemic including infections, non-SAE, Moderate	0.039	0.052
Systemic including infections, non-SAE, Severe	0.001	0.005
Systemic including infections, non-SAE, Total	0.175	0.221
Systemic including infections, SAE, Moderate	0.001	0
Systemic including infections, SAE, Severe	0.001	0
Systemic including infections, SAE, Total	0.001	0
Systemic excluding infections, non-SAE, Mild	0.123	0.156
Systemic excluding infections, non-SAE, Moderate	0.034	0.043
Systemic excluding infections, non-SAE, Severe	0.001	0.005
Systemic excluding infections, non-SAE, Total	0.158	0.204
Systemic excluding infections, SAE, Moderate	0.001	0
Systemic excluding infections, SAE, Severe	0.001	0
Systemic excluding infections, SAE, Total	0.001	0

24. Secondary Outcome

Title	Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study
Description	[Not Specified]
Time Frame	Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	IGSC, 10% - rHuPH20	Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description:	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
Overall Number of Participants Analyzed	66	48
Overall Number of Units Analyzed; Type of Units Analyzed: Infusions	1600	598
Measure Type: Number; Unit of Measure: Percentage of infusions
Including Infections	8.8	3.7
Excluding Infections	8.7	3.7

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	IGSC, 10% - rHuPH20		Safety Follow-up - IGSC, 10% or IGIV, 10% Only
Arm/Group Description	Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).		All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study). At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant. Note: IGIV, 10% is the same product as IGSC, 10%.
All-Cause Mortality
	IGSC, 10% - rHuPH20		Safety Follow-up - IGSC, 10% or IGIV, 10% Only
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	IGSC, 10% - rHuPH20		Safety Follow-up - IGSC, 10% or IGIV, 10% Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/63 (14.29%)		3/51 (5.88%)
Cardiac disorders
Aortic Valve Incompetence	1/63 (1.59%)	1	0/51 (0.00%)	0
Atrial Fibrillation	1/63 (1.59%)	1	0/51 (0.00%)	0
Cardiac Failure Congestive	1/63 (1.59%)	1	0/51 (0.00%)	0
Infections and infestations
Appendicitis	1/63 (1.59%)	1	0/51 (0.00%)	0
Cellulitis	0/63 (0.00%)	0	1/51 (1.96%)	1
Cryptosporidiosis Infection	1/63 (1.59%)	1	0/51 (0.00%)	0
Pneumonia Pseudomonas Aeruginosa	1/63 (1.59%)	1	0/51 (0.00%)	0
Injury, poisoning and procedural complications
Femur Fracture	0/63 (0.00%)	0	1/51 (1.96%)	1
Toxicity to Various Agents	1/63 (1.59%)	1	0/51 (0.00%)	0
Nervous system disorders
Spinal Meningeal Cyst	1/63 (1.59%)	1	0/51 (0.00%)	0
Transient Ischaemic Attack	0/63 (0.00%)	0	1/51 (1.96%)	1
Psychiatric disorders
Mental Status Changes	1/63 (1.59%)	1	0/51 (0.00%)	0
Reproductive system and breast disorders
Cystocele	1/63 (1.59%)	1	0/51 (0.00%)	0
Vaginal Prolapse	1/63 (1.59%)	1	0/51 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	1/63 (1.59%)	2	0/51 (0.00%)	0
Surgical and medical procedures
Adhesiolysis	1/63 (1.59%)	1	0/51 (0.00%)	0
Vascular disorders
Hypertension	1/63 (1.59%)	1	0/51 (0.00%)	0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	IGSC, 10% - rHuPH20		Safety Follow-up - IGSC, 10% or IGIV, 10% Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/63 (95.24%)		45/51 (88.24%)
Blood and lymphatic system disorders
Lymphadenopathy	5/63 (7.94%)	5	1/51 (1.96%)	2
Cardiac disorders
Tachycardia	5/63 (7.94%)	6	1/51 (1.96%)	1
Gastrointestinal disorders
Abdominal Pain	4/63 (6.35%)	7	2/51 (3.92%)	4
Abdominal Pain Upper	7/63 (11.11%)	8	0/51 (0.00%)	0
Apthous Stomatitis	4/63 (6.35%)	7	2/51 (3.92%)	2
Constipation	6/63 (9.52%)	6	1/51 (1.96%)	3
Diarrhoea	13/63 (20.63%)	19	3/51 (5.88%)	5
Gastrooesophageal Reflux	4/63 (6.35%)	4	0/51 (0.00%)	0
Nausea	16/63 (25.40%)	46	4/51 (7.84%)	25
Vomiting	13/63 (20.63%)	17	2/51 (3.92%)	4
General disorders
Asthenia	4/63 (6.35%)	16	1/51 (1.96%)	1
Fatigue	11/63 (17.46%)	27	5/51 (9.80%)	23
Infusion Site Discomfort	5/63 (7.94%)	8	1/51 (1.96%)	2
Infusion Site Erythema	12/63 (19.05%)	23	0/51 (0.00%)	0
Infusion site Pain	16/63 (25.40%)	84	2/51 (3.92%)	19
Infusion Site Pruritus	6/63 (9.52%)	31	0/51 (0.00%)	0
Oedema Peripheral	3/63 (4.76%)	8	6/51 (11.76%)	6
Pain	4/63 (6.35%)	9	0/51 (0.00%)	0
Pyrexia	10/63 (15.87%)	16	4/51 (7.84%)	5
Infections and infestations
Bronchitis	14/63 (22.22%)	22	6/51 (11.76%)	7
Cellulitis	4/63 (6.35%)	4	1/51 (1.96%)	1
Chronic Sinusitis	5/63 (7.94%)	8	2/51 (3.92%)