Trial Outcomes & Findings for Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID (NCT NCT01175213)

Last Updated: 2021-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

66 participants

Primary outcome timeframe

Throughout the efficacy period only (from 60 to 729 days)

Results posted on

2021-05-19

Participant Flow

Recruitment was conducted 11 clinical sites in the United States.

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.

Participant milestones

Participant milestones
Measure	IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only 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%.	IGIV, 10% Only 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%.
Safety Follow-up STARTED	48	3
Safety Follow-up COMPLETED	47	3
IGSC, 10%/rHuPH20 STARTED	63	3
IGSC, 10%/rHuPH20 COMPLETED	48	3
IGSC, 10%/rHuPH20 NOT COMPLETED	15	0
Safety Follow-up NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only 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%.	IGIV, 10% Only 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%.
IGSC, 10%/rHuPH20 Withdrawal by Subject	4	0
IGSC, 10%/rHuPH20 Death	1	0
IGSC, 10%/rHuPH20 bone marrow transplant	1	0
IGSC, 10%/rHuPH20 clinical site closed by sponsor	6	0
IGSC, 10%/rHuPH20 site elected to exit study	3	0
Safety Follow-up Adverse Event	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Aged 2 to <12 Years n=4 Participants	Participants Aged 12 to <16 Years n=7 Participants	Participants Aged 16 to <65 Years n=47 Participants	Participants Aged 65 Years and Older n=8 Participants	Total n=66 Participants Total of all reporting groups
Age, Continuous	10.5 Years n=5 Participants	15.0 Years n=7 Participants	47.0 Years n=5 Participants	71.0 Years n=4 Participants	43.0 Years n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	23 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants	1 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment United States	4 Participants n=5 Participants	7 Participants n=7 Participants	47 Participants n=5 Participants	8 Participants n=4 Participants	66 Participants n=21 Participants

PRIMARY outcome

Timeframe: Throughout the efficacy period only (from 60 to 729 days)

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Annual Rate of Serious Bacterial Infections	0.020 Estimated infections/year	—

PRIMARY outcome

Timeframe: Throughout the efficacy period only (from 60 to 729 days)

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

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Annual Rate of All Infections	2.86 Number of infections/year Interval 2.36 to 3.43	—

PRIMARY outcome

Timeframe: Throughout the efficacy period only (from 60 to 729 days)

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=66 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency 3-Week Treatment Interval [N=9]	12.300 g/L Interval 11.5 to 15.3	—
Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency 4-Week Treatment Interval [N=47]	9.760 g/L Interval 9.26 to 10.7	—
Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency 2-Week Treatment Interval [N=17]	10.900 g/L Interval 9.39 to 13.3	—

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set

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).

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 2 to <12 years - not related	0.0000 SAEs/year	0.0000 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 2 to <12 years - related	0.0000 SAEs/year	0.0000 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 12 to <16 years - not related	0.0768 SAEs/year	0.0000 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 12 to <16 years - related	0.0000 SAEs/year	0.0000 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 16 to <65 years - not related	0.0950 SAEs/year	0.0449 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 16 to <65 years - related	0.0000 SAEs/year	0.0000 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 65 years and older- not related	0.5737 SAEs/year	0.4728 SAEs/year
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs Participants aged 65 years and older- related	0.0000 SAEs/year	0.0000 SAEs/year

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs Percentage of infusion rates reduced	1.3 Percentage of infusions	0.3 Percentage of infusions
Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs Percentage of infusions interrupted	0.8 Percentage of infusions	0.2 Percentage of infusions
Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs Percentage of infusions stopped	0.1 Percentage of infusions	0.2 Percentage of infusions

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
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 Excluding Infections	2.9 Percentage of infusions	4.0 Percentage of infusions
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 Including Infections	3.4 Percentage of infusions	4.7 Percentage of infusions

SECONDARY outcome

Timeframe: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

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

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=66 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 Binding antibodies (>=1:160)	13 Number of participants	—
Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 Neutralizing antibodies	0 Number of participants	—

SECONDARY outcome

Timeframe: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=66 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 Binding antibodies (>=1:160)	19.7 Percentage of participants	—
Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 Neutralizing antibodies	0 Percentage of participants	—

SECONDARY outcome

Timeframe: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=13 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Number of Participants With AEs Related to Anti-rHuPH20 Titers	12 Number of participants	—

SECONDARY outcome

Timeframe: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=13 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only 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%.
Percentage of Participants With AEs Related to Anti-rHuPH20 Titers	92.3 Percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Distension-non-SAE-R-Mild	6 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Hernia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Mass-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain-non-SAE-NR-Mod	4 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain-non-SAE-NR-Severe	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain-non-SAE-R-Mild	0 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain Upper-non-SAE-NR-Mild	7 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Pain Upper-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Tenderness-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abdominal Tenderness-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Abnormal Loss Of Weight-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acarodermatitis-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acarodermatitis-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acne-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acne-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Actinic Keratosis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Actinic Keratosis-non-SAE-NR-Mod	1 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Activities of Daily Living Impaired-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acute Sinusitis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acute Sinusitis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Acute Stress Disorder-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Adhesiolysis-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Age Related Macular Degeneration-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Agitation-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aldolase Increased-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Anaphylactic Reaction-non-SAE-R-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Animal Bite-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Animal Scratch-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Anxiety-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Anxiety-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aortic Calcification-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aortic Stenosis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aortic Stenosis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aortic Valve Incompetence-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Aortic Valve Incompetence-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Apthous Stomatitis-non-SAE-NR-Mild	4 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Apthous Stomatitis-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Apthous Stomatitis-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Appendicitis-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Application Site Erythema-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Arteritis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Arthralgia-non-SAE-NR-Mild	7 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Arthralgia-non-SAE-NR-Mod	0 Number of AEs	6 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Arthralgia-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Arthropod Bite-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthenia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthenia-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthenia-non-SAE-R-Mild	6 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthenia-non-SAE-R-Mod	7 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthma-non-SAE-NR-Mild	12 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Asthma-non-SAE-NR-Mod	20 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ataxia-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Atelectasis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Atrial Fibrillation-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Atrial Fibrillation-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). ADHD-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Back Pain-non-SAE-NR-Mild	3 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Back Pain-non-SAE-NR-Mod	3 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Back Pain-non-SAE-R-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Basal Cell Carcinoma-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Basal Cell Carcinoma-non-SAE-NR-Mod	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blepharochalasis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blister-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Bicarbonate Decreased-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood CPK Increased-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood CPK Increased-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Creatinine Increased-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Creatinine Increased-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Glucose Increased-non-SAE-NR-Mild	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Urea Increased-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Blood Urine Present-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Body Tinea-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Bone Pain-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Breast Calcifications-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Breast Dysplasia-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Bronchiolitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Bronchitis-non-SAE-NR-Mild	11 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Bronchitis-non-SAE-NR-Mod	11 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Burns Second Degree-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Bursitis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Candidiasis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cardiac Failure Congestive-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cardiac Murmur-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cardiomegaly-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cardiomegaly-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cardiomyopathy-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cataract-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cataract-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cellulitis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cellulitis-non-SAE-NR-Mod	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cellulitis-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cellulitis Male Ext. Genital Organ-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cerebral Sml Vessel Ischaemic Dis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cerumen Impaction-non-SAE-NR-Mild	2 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cervical Spinal Stenosis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chapped Lips-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cheilitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chest Discomfort-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chest Pain-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chest Pain-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chills-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chills-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chills-non-SAE-R-Mild	11 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cholelithiasis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chondromalacia-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chromaturia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). COPD-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). COPD-non-SAE-NR-Mod	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). COPD-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). COPD-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chronic Sinusitis-non-SAE-NR-Mild	5 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Chronic Sinusitis-non-SAE-NR-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctival Haemorrhage-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctival Hyperaemia-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctivitis-non-SAE-NR-Mild	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctivitis Allergic-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctivitis Allergic-non-SAE-NR-Mod	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Conjunctivitis Infective-non-SAE-NR-Mild	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Constipation-non-SAE-NR-Mild	3 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Constipation-non-SAE-NR-Mod	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Contusion-non-SAE-NR-Mild	0 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Convulsion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Convulsion-non-SAE-NR-Mod	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Coombs Direct Test Positive-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Coombs Test Positive-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Coombs Test Positive-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Corneal Abrasion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Costochondritis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Costochondritis-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cough-non-SAE-NR-Mild	10 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cough-non-SAE-NR-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cough-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cryptosporidiosis Infection-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cyst-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cyst-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cystitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Cystocele-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Decreased Appetite-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Decreased Appetite-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Decreased Appetite-non-SAE-R-Mild	3 Number of AEs	8 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dehydration-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dehydration-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dental Caries-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Depression-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Depression-non-SAE-NR-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermal Cyst-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis Allergic-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis Atopic-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis Contact-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis Contact-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dermatitis Psoriasiform-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Device Breakage-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Device Failure-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Diarrhoea-non-SAE-NR-Mild	15 Number of AEs	4 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Diarrhoea-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Diarrhoea-non-SAE-R-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dizziness-non-SAE-NR-Mild	5 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dizziness-non-SAE-R-Mild	5 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dizziness-non-SAE-R-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Drug Eruption-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Drug Hypersensitivity-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dry Eye-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dry Eye-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dry Mouth-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dry Skin-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dysmenorrhoea-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dyspepsia-non-SAE-NR-Mild	0 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dysplastic Naevus-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dyspnoea-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dyspnoea-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dysuria-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Dysuria-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ear Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ear Infection-non-SAE-NR-Mod	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ear Pain-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ear Pain-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Ear Pruritus-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eccymosis-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eccymosis-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eczema-non-SAE-NR-Mild	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eczema-non-SAE-NR-Mod	5 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Empty Sella Syndrome-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Epilepsy-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Epitaxis-non-SAE-NR-Mild	11 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Erythema-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eschar-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Excoriation-non-SAE-NR-Mild	8 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Excoriation-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eye Haemorrhage-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eye Infection-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eye Pain-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eye Swelling-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Eyelid Ptosis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Facial Bones Fracture-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Facial Pain-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fall-non-SAE-NR-Mild	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fall-non-SAE-NR-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fatigue-non-SAE-NR-Mild	7 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fatigue-non-SAE-NR-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fatigue-non-SAE-NR-Severe	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fatigue-non-SAE-R-Mild	13 Number of AEs	14 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fatigue-non-SAE-R-Mod	3 Number of AEs	7 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Femur Fracture-SAE-NR-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fibromyalgia-non-SAE-NR-Mod	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Flatulence-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Flushing-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Folliculitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Food Poisoning-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Food Poisoning-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Foot Fracture-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Free Haemoglobin Present-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Free Haemoglobin Present-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Free Haemoglobin Present-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Free Haemoglobin Present-non-SAE-R-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Frequent Bowel Movements-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fungal Infection-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). Fungal Skin Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Genital Herpes-non-SAE-NR-Mild	2 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Genital Herpes-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gingival Erosion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastric Stenosis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastritis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastroenteritis-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastroenteritis-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastroenteritis Salmonella-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastroenteritis Viral-non-SAE-NR-Mild	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastroenteritis Viral-non-SAE-NR-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gastrointestinal Viral Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gingivitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Glaucoma-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Glycosuria-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Gout-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haematochezia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haematospermia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haematuria-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haemoglobin Decreased-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haemolysis-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haemorrhoids-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Haemorrhoids-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hand Fracture-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Headache-non-SAE-NR-Mild	22 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Headache-non-SAE-NR-Mod	4 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Headache-non-SAE-R-Mild	19 Number of AEs	34 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Headache-non-SAE-R-Mod	2 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Heart Rate Irregular-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Herpes Zoster-non-SAE-NR-Mod	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hiatus Hernia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hydrocele-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypercapnia-non-SAE-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypercholesterolaemia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypersensitivity-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypertension-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypertension-non-SAE-NR-Mod	6 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypertension-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypoaesthesia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypokalaemia-non-SAE-NR-Mild	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypothyroidism-non-SAE-NR-Mild	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Hypothyroidism-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Impetigo-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Incision Site Pain-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Increased Upper Airway Secretion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Inflammation Of Wound-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Influenza-non-SAE-NR-Mod	6 Number of AEs	4 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Influenza Like Illness-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Influenza Like Illness-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Abscess-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Bruising-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Discolouration-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Discomfort-non-SAE-R-Mild	8 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Erythema-non-SAE-R-Mild	22 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Erythema-non-SAE-R-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Induration-non-SAE-R-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Mass-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Oedema-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Pain-non-SAE-NR-Mod	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Pain-non-SAE-R-Mild	78 Number of AEs	17 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Pain-non-SAE-R-Mod	6 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Pruritus-non-SAE-R-Mild	31 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Swelling-non-SAE-R-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Infusion Site Swelling-non-SAE-R-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Injection Site Pain-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Injection Site Pain-non-SAE-R-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Insomnia-non-SAE-NR-Mild	5 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Insomnia-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Intervertebral Disc Degeneration-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Iron Deficiency Anaemia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Irritable Bowel Syndrome-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Jejunal Stenosis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Joint Dislocation-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Joint Injury-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Joint Swelling-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Laceration-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Ligament Sprain-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Ligament Sprain-non-SAE-NR-Mod	1 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Limb Discomfort-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Liver Function Test Abnormal-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Local Swelling-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Local Swelling-non-SAE-R-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Localised Infection-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Loss Of Consciousness-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lyme Disease-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lymph Gland Infection-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lymphadenitis-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lymphadenitis Bacterial-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lymphadenopathy-non-SAE-NR-Mild	5 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Lymphopenia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Malaise-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Malaise-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Medical Device Pain-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Memory Impairment-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Meniscus Injury-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Menstrual Disorder-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Mental Status Changes-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Micturition Urgency-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Middle Ear Effusion-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Migraine-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Migraine-non-SAE-NR-Mod	2 Number of AEs	4 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Migraine-non-SAE-NR-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Migraine-non-SAE-R-Mild	1 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Migraine-non-SAE-R-Mod	3 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Mitral Valve Incompetence-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Molluscum Contagiosum-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Mouth Ulceration-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Mucosal Inflammation-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Muscle Contractions Involuntary-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Muscle Spasms-non-SAE-NR-Mild	4 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Muscle Strain-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Muscular Weakness-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Muscular Weakness-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Musculoskeletal Pain-non-SAE-NR-Mild	4 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Musculoskeletal Pain-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Myalgia-non-SAE-NR-Mild	2 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Myalgia-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Myalgia-non-SAE-R-Mild	23 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). Myalgia-non-SAE-R-Mod	3 Number of AEs	1 Number of AEs

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Post Procedural Haemorrhage-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Post Procedural Swelling-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Procedural Nausea-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Procedural Pain-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Procedural Pain-non-SAE-NR-Mod	9 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Proctalgia-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Productive Cough-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Protein Urine Present-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pruritus-non-SAE-NR-Mild	3 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pruritus-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pruritus-non-SAE-R-Mild	0 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pruritus Allergic-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pruritus Generalised-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pulmonary Hypertension-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pulmonary Hypertension-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pulmonary Vascular Disorder-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Puncture Site Pain-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Puncture Site Pain-non-SAE-NR-Mod	0 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Purpura Senile-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pyogenic Granuloma-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pyrexia-non-SAE-NR-Mild	11 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pyrexia-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pyrexia-non-SAE-R-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pyuria-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rales-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rash-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rash Generalised-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rectal Polyp-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Red Blood Cells Urine Positive-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Respiratory Tract Congestion-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Respiratory Tract Congestion-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Respiratory Tract Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Respiratory Tract Infection-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Restless Legs Syndrome-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rhinitis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rhinitis Perennial-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rhinorrhoea-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rhinorrhoea-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Right Atrial Dilatation-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Rotator Cuff Syndrome-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Scab-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Scar-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Scoliosis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Scratch-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Scrotal Swelling-non-SAE-R-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Seborrhoeic Keratosis-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sinus Congestion-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sinus Headache-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sinusitis-non-SAE-NR-Mild	34 Number of AEs	3 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sinusitis-non-SAE-NR-Mod	29 Number of AEs	13 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Skin Hyperpigmentation-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Skin Lesion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Skin Mass-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sleep Apnoea Syndrome-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Slow Speech-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Solar Lentigo-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Somnolence-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Speech Disorder-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Spermatocele-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Spinal Compression Fracture-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Spinal Meningeal Cyst-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Spinal Osteoarthritis-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Squamous Cell Carcinoma-non-SAE-NR-Mod	4 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Stress-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Suicide Attempt-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Sunburn-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Swelling Face-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Swelling Face-non-SAE-NR-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Swollen Tongue-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Synovial Cyst-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tachycardia-non-SAE-NR-Mild	5 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tachycardia-non-SAE-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tendon Disorder-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tendonitis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tendonitis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Testicular Microlithiasis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Testicular Pain-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Thermal Burn-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Thinking Abnormal-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Thrombocytopenia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tibia Fracture-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tinea Cruris-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tinea Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tooth Abscess-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tooth Abscess-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tooth Fracture-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tooth Infection-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tooth Infection-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Toothache-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Toxicity To Various Agents-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tracheal Stenosis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Transient Ischaemic Attack-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Traumatic Haematoma-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tricuspid Valve Incompetence-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Trigeminal Neuralgia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Tympanic Membrane Scarring-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Type 2 Diabetes Mellitus-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Upper Limb Fracture-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Upper Limb Fracture-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-NR-Mild	16 Number of AEs	8 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-NR-Mod	13 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Upper-Airway Cough Syndrome-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Urethritis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Urinary Tract Infection-non-SAE-NR-Mild	4 Number of AEs	4 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Urinary Tract Infection-non-SAE-NR-Mod	6 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Urticaria-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Urticaria-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Uterine Polyp-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vaginal Prolapse-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vaginitis Bacterial-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Varicose Vein-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vasomotor Rhinitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vein Pain-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Ventricular Hypokinesia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vessel Puncture Site Bruise-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Infection-non-SAE-NR-Mild	3 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Infection-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Pharyngitis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Pharyngitis-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Rash-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mild	29 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vision Blurred-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vitamin B12 Deficiency-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vitamin D Decreased-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vitamin D Deficiency-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vitamin D Deficiency-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vomiting-non-SAE-NR-Mild	13 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vomiting-non-SAE-NR-Mod	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vomiting-non-SAE-R-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vulvar Dysplasia-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vulvovaginal Candidiasis-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-NR-Mild	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Wheezing-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Wisdom Teeth Removal-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Wisdom Teeth Removal-non-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Wound-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Wrist Fracture-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Xeroderma-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nasal Congestion-non-SAE-NR-Mild	11 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nasal Congestion-non-SAE-NR-Mod	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nasal Discomfort-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nasopharyngitis-non-SAE-NR-Mild	7 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nasopharyngitis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nausea-non-SAE-NR-Mild	14 Number of AEs	5 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nausea-non-SAE-NR-Mod	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nausea-non-SAE-R-Mild	25 Number of AEs	12 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nausea-non-SAE-R-Mod	3 Number of AEs	7 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nephrolithiasis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Nerve Compression-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Neutrophil Count Decreased-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Ocular Hyperaemia-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oedema Peripheral-non-SAE-NR-Mild	4 Number of AEs	4 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oedema Peripheral-non-SAE-NR-Mod	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oedema Peripheral-non-SAE-R-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oral Candidiasis-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oral Herpes-non-SAE-NR-Mild	7 Number of AEs	2 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oral Pain-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oral Pain-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Orchitis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Oropharyngeal Pain-non-SAE-NR-Mild	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Osteoarthritis-non-SAE-NR-Mild	2 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Osteoarthritis-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Osteopenia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Osteoporosis-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Otitis Externa-non-SAE-NR-Mild	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Otitis Externa-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Otitis Media-non-SAE-NR-Mod	1 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pain-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pain-non-SAE-R-Mild	7 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pain In Extremity-non-SAE-NR-Mild	4 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pain In Extremity-non-SAE-R-Sev	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Palpitations-non-SAE-NR-Mild	2 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Panic Attack-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Papule-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Paraesthesia-non-SAE-R-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Paranasal Cyst-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pelvic Pain-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pericardial Effusion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Perineurial Cyst-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Periodontal Disease-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pharyngitis-non-SAE-NR-Mild	6 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pharyngitis-non-SAE-NR-Mod	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pharyngitis Streptococcal-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pleural Effusion-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pleural Effusion-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pneumonia-non-SAE-NR-Mild	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pneumonia Bacterial-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pneumonia Pseudomonas Aeruginosa-SAE-NR-Sev	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pollakiuria-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Pollakiuria-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Polycystic Ovaries-non-SAE-NR-Mild	0 Number of AEs	1 Number of AEs
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). Post Procedural Complication-non-SAE-NR-Mod	1 Number of AEs	0 Number of AEs

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Actinic Keratosis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Distension-non-SAE-Mild	0.095 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Hernia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Mass-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Mild	0.032 Number of AEs per participant	0.078 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Mod	0.063 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain Upper-non-SAE-Mild	0.127 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Tenderness-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abnormal Loss of Weight-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acarodermatitis-non-SAE-Mild	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acarodermatitis-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acne-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acne-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Actinic Keratosis-non-SAE-Mod	0.016 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Activities of Daily Living Impaired-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Sinusitis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Sinusitis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Stress Disorder-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Adhesiolysis-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Age-Related Macular Degeneration-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Agitation-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aldolase Increased-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anaphylactic Reaction-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Animal Bite-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Animal Scratch-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anxiety-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anxiety-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Calcification-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Stenosis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Stenosis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Valve Incompetence-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Valve Incompetence-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aphthous Stomatitis-non-SAE-Mild	0.079 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aphthous Stomatitis-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Appendicitis-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Application Site Erythema-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arteritis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthralgia-non-SAE-Mild	0.127 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthralgia-non-SAE-Mod	0 Number of AEs per participant	0.118 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthropod Bite-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthenia-non-SAE-Mild	0.111 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthenia-non-SAE-Mod	0.143 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthma-non-SAE-Mild	0.190 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthma-non-SAE-Mod	0.317 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ataxia-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atelectasis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atrial Fibrillation-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atrial Fibrillation-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). ADHD-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Mild	0.048 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Mod	0.048 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Basal Cell Carcinoma-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Basal Cell Carcinoma-non-SAE-Mod	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blepharochalasis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blister-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Bicarbonate Decreased-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatine Phosphokinase Inc.-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatine Phosphokinase Inc.-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatinine Increased-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Glucose Increased-non-SAE-Mild	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Urea Increased-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Urine Present-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Body Tinea-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bone Pain-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Breast Calcifications-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Breast Dysplasia-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchiolitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchitis-non-SAE-Mild	0.175 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchitis-non-SAE-Mod	0.175 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Burns Second Degree-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bursitis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Candidiasis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiac Failure Congestive-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiac Murmur-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomegaly-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomegaly-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomyopathy-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cataract-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cataract-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-non-SAE-Mod	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis Of Male Ext Genital Organ-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cerumen Impaction-non-SAE-Mild	0.032 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cervical Spinal Stenosis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chapped Lips-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cheilitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Discomfort-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Pain-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Pain-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chills-non-SAE-Mild	0.206 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chills-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cholelithiasis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chondromalacia-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chromaturia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-non-SAE-Mod	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chronic Sinusitis-non-SAE-Mild	0.079 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chronic Sinusitis-non-SAE-Mod	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctival Haemorrhage-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctival Hyperaemia-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis-non-SAE-Mild	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Allergic-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Allergic-non-SAE-Mod	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Infective-non-SAE-Mild	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Constipation-non-SAE-Mild	0.048 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Constipation-non-SAE-Mod	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Contusion-non-SAE-Mild	0 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Convulsion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Convulsion-non-SAE-Mod	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Coombs Direct Test Positive-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Coombs Test Positive-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Corneal Abrasion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Costochondritis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Costochondritis-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cough-non-SAE-Mild	0.175 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cough-non-SAE-Mod	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cryptosporidiosis Infection-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cyst-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cyst-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cystitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cystocele-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Decreased Appetite-non-SAE-Mild	0.063 Number of AEs per participant	0.157 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Decreased Appetite-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dehydration-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dehydration-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dental Caries-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Depression-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Depression-non-SAE-Mod	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermal Cyst-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Allergic-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Atopic-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Contact-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Contact-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Psoriasiform-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Device Breakage-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Device Failure-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Diarrhoea-non-SAE-Mild	0.270 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Diarrhoea-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dizziness-non-SAE-Mild	0.159 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dizziness-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Drug Eruption-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Drug Hypersensitivity-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Eye-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Eye-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Mouth-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Skin-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysmenorrhoea-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspepsia-non-SAE-Mild	0 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysplastic Naevus-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspnoea-non-SAE-Mild	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspnoea-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysuria-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysuria-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Infection-non-SAE-Mod	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pain-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pain-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pruritus-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ecchymosis-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ecchymosis-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eczema-non-SAE-Mild	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eczema-non-SAE-Mod	0.079 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Empty Sella Syndrome-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Epilepsy-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Epistaxis-non-SAE-Mild	0.175 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Erythema-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eschar-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Excoriation-non-SAE-Mild	0.127 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Excoriation-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Haemorrhage-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Infection-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Pain-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Swelling-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eyelid Ptosis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Facial Bones Fracture-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Facial Pain-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fall-non-SAE-Mild	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fall-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Mild	0.317 Number of AEs per participant	0.294 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Mod	0.095 Number of AEs per participant	0.157 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Femur Fracture-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fibromyalgia-non-SAE-Mod	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Flatulence-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Flushing-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Folliculitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Food Poisoning-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Food Poisoning-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Foot Fracture-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Free Haemoglobin Present-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Free Haemoglobin Present-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Frequent Bowel Movements-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fungal Infection-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fungal Skin Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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)

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastric Stenosis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastritis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Salmonella-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Viral-non-SAE-Mild	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Viral-non-SAE-Mod	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrointestinal Viral Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Genital Herpes-non-SAE-Mild	0.032 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Genital Herpes-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gingival Erosion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gingivitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Glaucoma-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Glycosuria-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gout-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematochezia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematospermia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematuria-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemoglobin Decreased-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemolysis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemorrhoids-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemorrhoids-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hand Fracture-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Headache-non-SAE-Mild	0.651 Number of AEs per participant	0.765 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Headache-non-SAE-Mod	0.095 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Heart Rate Irregular-non-SAE-Mild	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Herpes Zoster-non-SAE-Mod	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hiatus Hernia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hydrocele-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypercapnia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypercholesterolaemia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypersensitivity-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-non-SAE-Mod	0.095 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypoaesthesia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypokalaemia-non-SAE-Mild	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypothyroidism-non-SAE-Mild	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypothyroidism-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Impetigo-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Incision Site Pain-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Increased Upper Airway Secretion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Inflammation Of Wound-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza-non-SAE-Mod	0.095 Number of AEs per participant	0.078 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza Like Illness-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza Like Illness-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Abscess-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Bruising-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Discolouration-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Discomfort-non-SAE-Mild	0.127 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Erythema-non-SAE-Mild	0.349 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Erythema-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Induration-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Mass-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Oedema-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pain-non-SAE-Mild	1.238 Number of AEs per participant	0.333 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pain-non-SAE-Mod	0.095 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pruritus-non-SAE-Mild	0.492 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Swelling-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Swelling-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Injection Site Pain-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Insomnia-non-SAE-Mild	0.079 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Insomnia-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Intervertebral Disc Degeneration-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Iron Deficiency Anaemia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Irritable Bowel Syndrome-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Jejunal Stenosis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Dislocation-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Injury-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Swelling-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Laceration-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Ligament Sprain-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Ligament Sprain-non-SAE-Mod	0.016 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Limb Discomfort-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Liver Function Test Abnormal-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Local Swelling-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Localised Infection-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Loss Of Consciousness-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lyme Disease-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymph Gland Infection-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenitis-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenitis Bacterial-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenopathy-non-SAE-Mild	0.079 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphopenia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Malaise-non-SAE-Mild	0.048 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Medical Device Pain-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Memory Impairment-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Meniscus Injury-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Menstrual Disorder-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mental Status Changes-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Micturition Urgency-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Middle Ear Effusion-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Mild	0.063 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Mod	0.079 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mitral Valve Incompetence-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Molluscum Contagiosum-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mouth Ulceration-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mucosal Inflammation-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Contractions Involuntary-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Spasms-non-SAE-Mild	0.063 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Strain-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscular Weakness-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscular Weakness-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Musculoskeletal Pain-non-SAE-Mild	0.063 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Musculoskeletal Pain-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Myalgia-non-SAE-Mild	0.397 Number of AEs per participant	0.118 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Myalgia-non-SAE-Mod	0.048 Number of AEs per participant	0.039 Number of AEs per participant

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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)

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Congestion-non-SAE-Mild	0.175 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Congestion-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Discomfort-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasopharyngitis-non-SAE-Mild	0.111 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasopharyngitis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nausea-non-SAE-Mild	0.619 Number of AEs per participant	0.333 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nausea-non-SAE-Mod	0.111 Number of AEs per participant	0.157 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nephrolithiasis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nerve Compression-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Neutrophil Count Decreased-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Ocular Hyperaemia-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oedema Peripheral-non-SAE-Mild	0.063 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oedema Peripheral-non-SAE-Mod	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Candidiasis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Herpes-non-SAE-Mild	0.111 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Pain-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Pain-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Orchitis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oropharyngeal Pain-non-SAE-Mild	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoarthritis-non-SAE-Mild	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoarthritis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteopenia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoporosis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Externa-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Externa-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Media-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain-non-SAE-Mild	0.143 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain In Extremity-non-SAE-Mild	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain In Extremity-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Palpitations-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Panic Attack-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Papule-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Paraesthesia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Paranasal Cyst-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pelvic Pain-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pericardial Effusion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Perineurial Cyst-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Periodontal Disease-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis-non-SAE-Mild	0.095 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis Streptococcal-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pleural Effusion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pleural Effusion-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia Bacterial-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia Pseudomonas Aeruginosa-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pollakiuria-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pollakiuria-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Polycystic Ovaries-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Complication-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Haemorrhage-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Swelling-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Nausea-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Pain-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Pain-non-SAE-Mod	0.143 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Proctalgia-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Productive Cough-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Protein Urine Present-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus-non-SAE-Mild	0.048 Number of AEs per participant	0.118 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus Allergic-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus Generalised-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Hypertension-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Hypertension-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Vascular Disorder-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Puncture Site Pain-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Puncture Site Pain-non-SAE-Mod	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Purpura Senile-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyogenic Granuloma-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyrexia-non-SAE-Mild	0.222 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyrexia-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyuria-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rales-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rash-non-SAE-Mild	0.032 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rash Generalised-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rectal Polyp-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Red Blood Cells Urine Positive-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Congestion-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Congestion-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Infection-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Restless Legs Syndrome-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinitis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinitis Perennial-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinorrhoea-non-SAE-Mild	0.032 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Right Atrial Dilatation-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rotator Cuff Syndrome-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scab-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scar-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scoliosis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scratch-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scrotal Swelling-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Seborrhoeic Keratosis-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinus Congestion-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinus Headache-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinusitis-non-SAE-Mild	0.540 Number of AEs per participant	0.059 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinusitis-non-SAE-Mod	0.460 Number of AEs per participant	0.255 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Hyperpigmentation-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Lesion-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Mass-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sleep Apnoea Syndrome-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Slow Speech-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Solar Lentigo-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Somnolence-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Speech Disorder-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spermatocele-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Compression Fracture-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Meningeal Cyst-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Osteoarthritis-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Squamous Cell Carcinoma-non-SAE-Mod	0.063 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Stress-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Suicide Attempt-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sunburn-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swelling Face-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swelling Face-non-SAE-Sev	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swollen Tongue-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Synovial Cyst-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tachycardia-non-SAE-Mild	0.079 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tachycardia-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendon Disorder-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendonitis-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendonitis-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Testicular Microlithiasis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Testicular Pain-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thermal Burn-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thinking Abnormal-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thrombocytopenia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tibia Fracture-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tinea Cruris-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tinea Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Abscess-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Abscess-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Fracture-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Infection-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Infection-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Toothache-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Toxicity To Various Agents-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tracheal Stenosis-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Transient Ischaemic Attack-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Traumatic Haematoma-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tricuspid Valve Incompetence-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Trigeminal Neuralgia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tympanic Membrane Scarring-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Type 2 Diabetes Mellitus-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Limb Fracture-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Limb Fracture-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-Mild	0.254 Number of AEs per participant	0.157 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-Mod	0.206 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper-Airway Cough Syndrome-non-SAE-Mild	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urethritis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urinary Tract Infection-non-SAE-Mild	0.063 Number of AEs per participant	0.078 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urinary Tract Infection-non-SAE-Mod	0.095 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urticaria-non-SAE-Mild	0 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Uterine Polyp-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vaginal Prolapse-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vaginitis Bacterial-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Varicose Vein-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vasomotor Rhinitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vein Pain-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Ventricular Hypokinesia-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vessel Puncture Site Bruise-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Infection-non-SAE-Mild	0.048 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Infection-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Pharyngitis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Pharyngitis-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Rash-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Upper Respiratory Tract Inf.-non-SAE-Mild	0.460 Number of AEs per participant	0.098 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Upper Respiratory Tract Inf-non-SAE-Mod	0.016 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vision Blurred-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin B12 Deficiency-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Decreased-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Deficiency-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Deficiency-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vomiting-non-SAE-Mild	0.206 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vomiting-non-SAE-Mod	0.063 Number of AEs per participant	0.039 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvar Dysplasia-non-SAE-Mild	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Candidiasis-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-Mild	0.063 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-Mod	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wheezing-non-SAE-Mod	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wisdom Teeth Removal-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wisdom Teeth Removal-non-SAE-Sev	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wound-non-SAE-Mild	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wrist Fracture-non-SAE-Mod	0 Number of AEs per participant	0.020 Number of AEs per participant
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Xeroderma-non-SAE-Mild	0.016 Number of AEs per participant	0 Number of AEs per participant

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Distension-non-SAE-Mild	0.004 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Hernia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Mass-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Mild	0.001 Number of AEs per infusion	0.007 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Mod	0.003 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain-non-SAE-Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Pain Upper-non-SAE-Mild	0.005 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abdominal Tenderness-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Abnormal Loss of Weight-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acarodermatitis-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acarodermatitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acne-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acne-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Actinic Keratosis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Actinic Keratosis-non-SAE-Mod	0.001 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Activities of Daily Living Impaired-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Sinusitis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Sinusitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Acute Stress Disorder-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Adhesiolysis-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Age-Related Macular Degeneration-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Agitation-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aldolase Increased-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anaphylactic Reaction-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Animal Bite-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Animal Scratch-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anxiety-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Anxiety-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Calcification-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Stenosis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Stenosis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Valve Incompetence-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aortic Valve Incompetence-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aphthous Stomatitis-non-SAE-Mild	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Aphthous Stomatitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Appendicitis-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Application Site Erythema-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arteritis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthralgia-non-SAE-Mild	0.005 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthralgia-non-SAE-Mod	0 Number of AEs per infusion	0.010 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Arthropod Bite-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthenia-non-SAE-Mild	0.004 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthenia-non-SAE-Mod	0.006 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthma-non-SAE-Mild	0.008 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Asthma-non-SAE-Mod	0.013 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ataxia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atelectasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atrial Fibrillation-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Atrial Fibrillation-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). ADHD-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Mild	0.002 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Mod	0.002 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Back Pain-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Basal Cell Carcinoma-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Basal Cell Carcinoma-non-SAE-Mod	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blepharochalasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blister-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Bicarbonate Decreased-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatine Phosphokinase Inc.-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatine Phosphokinase Inc.-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Creatinine Increased-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Glucose Increased-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Urea Increased-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Blood Urine Present-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Body Tinea-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bone Pain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Breast Calcifications-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Breast Dysplasia-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchiolitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchitis-non-SAE-Mild	0.007 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bronchitis-non-SAE-Mod	0.007 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Burns Second Degree-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Bursitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Candidiasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiac Failure Congestive-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiac Murmur-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomegaly-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomegaly-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cardiomyopathy-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cataract-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cataract-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cellulitis Of Male Ext Genital Organ-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cerumen Impaction-non-SAE-Mild	0.001 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cervical Spinal Stenosis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chapped Lips-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cheilitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Discomfort-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Pain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chest Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chills-non-SAE-Mild	0.008 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chills-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cholelithiasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chondromalacia-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chromaturia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-non-SAE-Mod	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). COPD-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chronic Sinusitis-non-SAE-Mild	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Chronic Sinusitis-non-SAE-Mod	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctival Haemorrhage-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctival Hyperaemia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis-non-SAE-Mild	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Allergic-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Allergic-non-SAE-Mod	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Conjunctivitis Infective-non-SAE-Mild	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Constipation-non-SAE-Mild	0.002 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Constipation-non-SAE-Mod	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Contusion-non-SAE-Mild	0 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Convulsion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Convulsion-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Coombs Direct Test Positive-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Coombs Test Positive-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Corneal Abrasion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Costochondritis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Costochondritis-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cough-non-SAE-Mild	0.007 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cough-non-SAE-Mod	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cryptosporidiosis Infection-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cyst-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cyst-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cystitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Cystocele-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Decreased Appetite-non-SAE-Mild	0.003 Number of AEs per infusion	0.013 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Decreased Appetite-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dehydration-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dehydration-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dental Caries-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Depression-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Depression-non-SAE-Mod	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermal Cyst-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Allergic-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Atopic-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Contact-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Contact-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dermatitis Psoriasiform-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Device Breakage-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Device Failure-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Diarrhoea-non-SAE-Mild	0.011 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Diarrhoea-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dizziness-non-SAE-Mild	0.006 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dizziness-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Drug Eruption-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Drug Hypersensitivity-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Eye-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Eye-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Mouth-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dry Skin-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysmenorrhoea-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspepsia-non-SAE-Mild	0 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysplastic Naevus-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspnoea-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dyspnoea-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysuria-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Dysuria-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Infection-non-SAE-Mod	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ear Pruritus-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ecchymosis-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Ecchymosis-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eczema-non-SAE-Mild	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eczema-non-SAE-Mod	0.003 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Empty Sella Syndrome-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Epilepsy-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Epistaxis-non-SAE-Mild	0.007 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Erythema-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eschar-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Excoriation-non-SAE-Mild	0.005 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Excoriation-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Haemorrhage-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Pain-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eye Swelling-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Eyelid Ptosis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Facial Bones Fracture-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Facial Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fall-non-SAE-Mild	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fall-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Mild	0.013 Number of AEs per infusion	0.025 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Mod	0.004 Number of AEs per infusion	0.013 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fatigue-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Femur Fracture-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fibromyalgia-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Flatulence-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Flushing-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Folliculitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Food Poisoning-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Food Poisoning-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Foot Fracture-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Free Haemoglobin Present-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Free Haemoglobin Present-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Frequent Bowel Movements-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fungal Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). Fungal Skin Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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)

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Glycosuria-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gout-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hand Fracture-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Headache-non-SAE-Mild	0.026 Number of AEs per infusion	0.065 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Headache-non-SAE-Mod	0.004 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Heart Rate Irregular-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Herpes Zoster-non-SAE-Mod	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematochezia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematospermia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haematuria-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemoglobin Decreased-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemolysis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemorrhoids-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Haemorrhoids-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastric Stenosis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastritis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Salmonella-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Viral-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastroenteritis Viral-non-SAE-Mod	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrointestinal Viral Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gastrooesophageal Reflux Disease-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Genital Herpes-non-SAE-Mild	0.001 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Genital Herpes-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gingival Erosion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Gingivitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Glaucoma-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hiatus Hernia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hydrocele-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypercapnia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypercholesterolaemia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypersensitivity-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-non-SAE-Mod	0.004 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypertension-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypoaesthesia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypokalaemia-non-SAE-Mild	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypothyroidism-non-SAE-Mild	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Hypothyroidism-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Impetigo-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Incision Site Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Increased Upper Airway Secretion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Inflammation Of Wound-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza-non-SAE-Mod	0.004 Number of AEs per infusion	0.007 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza Like Illness-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Influenza Like Illness-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Abscess-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Bruising-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Discolouration-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Discomfort-non-SAE-Mild	0.005 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Erythema-non-SAE-Mild	0.014 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Erythema-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Induration-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Mass-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Oedema-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pain-non-SAE-Mild	0.049 Number of AEs per infusion	0.028 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pain-non-SAE-Mod	0.004 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Pruritus-non-SAE-Mild	0.019 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Swelling-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Infusion Site Swelling-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Injection Site Pain-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Insomnia-non-SAE-Mild	0.003 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Insomnia-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Intervertebral Disc Degeneration-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Iron Deficiency Anaemia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Irritable Bowel Syndrome-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Jejunal Stenosis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Dislocation-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Injury-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Joint Swelling-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Laceration-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Ligament Sprain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Ligament Sprain-non-SAE-Mod	0.001 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Limb Discomfort-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Liver Function Test Abnormal-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Local Swelling-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Localised Infection-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Loss Of Consciousness-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lyme Disease-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymph Gland Infection-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenitis-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenitis Bacterial-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphadenopathy-non-SAE-Mild	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Lymphopenia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Malaise-non-SAE-Mild	0.002 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Medical Device Pain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Memory Impairment-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Meniscus Injury-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Menstrual Disorder-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mental Status Changes-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Micturition Urgency-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Middle Ear Effusion-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Mild	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Mod	0.003 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Migraine-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mitral Valve Incompetence-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Molluscum Contagiosum-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mouth Ulceration-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Mucosal Inflammation-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Contractions Involuntary-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Spasms-non-SAE-Mild	0.003 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscle Strain-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscular Weakness-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Muscular Weakness-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Musculoskeletal Pain-non-SAE-Mild	0.003 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Musculoskeletal Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Myalgia-non-SAE-Mild	0.016 Number of AEs per infusion	0.010 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). Myalgia-non-SAE-Mod	0.002 Number of AEs per infusion	0.003 Number of AEs per infusion

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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)

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteopenia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoporosis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Externa-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Externa-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Otitis Media-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain-non-SAE-Mild	0.006 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain In Extremity-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pain In Extremity-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Congestion-non-SAE-Mild	0.007 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Congestion-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasal Discomfort-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasopharyngitis-non-SAE-Mild	0.004 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nasopharyngitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nausea-non-SAE-Mild	0.024 Number of AEs per infusion	0.028 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nausea-non-SAE-Mod	0.004 Number of AEs per infusion	0.013 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nephrolithiasis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Nerve Compression-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Neutrophil Count Decreased-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Ocular Hyperaemia-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oedema Peripheral-non-SAE-Mild	0.003 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oedema Peripheral-non-SAE-Mod	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Candidiasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Herpes-non-SAE-Mild	0.004 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Pain-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oral Pain-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Orchitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Oropharyngeal Pain-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoarthritis-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Osteoarthritis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Palpitations-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Panic Attack-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Papule-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Paraesthesia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Paranasal Cyst-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pelvic Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pericardial Effusion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Perineurial Cyst-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Periodontal Disease-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis-non-SAE-Mild	0.004 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pharyngitis Streptococcal-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pleural Effusion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pleural Effusion-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia Bacterial-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pneumonia Pseudomonas Aeruginosa-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pollakiuria-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pollakiuria-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Polycystic Ovaries-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Complication-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Haemorrhage-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Post Procedural Swelling-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Nausea-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Pain-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Procedural Pain-non-SAE-Mod	0.006 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Proctalgia-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Productive Cough-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Protein Urine Present-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus-non-SAE-Mild	0.002 Number of AEs per infusion	0.010 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus Allergic-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pruritus Generalised-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Hypertension-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Hypertension-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pulmonary Vascular Disorder-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Puncture Site Pain-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Puncture Site Pain-non-SAE-Mod	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Purpura Senile-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyogenic Granuloma-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyrexia-non-SAE-Mild	0.009 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyrexia-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Pyuria-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rales-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rash-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rash Generalised-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rectal Polyp-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Red Blood Cells Urine Positive-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Congestion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Congestion-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Respiratory Tract Infection-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Restless Legs Syndrome-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinitis Perennial-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rhinorrhoea-non-SAE-Mild	0.001 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Right Atrial Dilatation-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Rotator Cuff Syndrome-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scab-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scar-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scoliosis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scratch-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Scrotal Swelling-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Seborrhoeic Keratosis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinus Congestion-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinus Headache-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinusitis-non-SAE-Mild	0.021 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sinusitis-non-SAE-Mod	0.018 Number of AEs per infusion	0.022 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Hyperpigmentation-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Lesion-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Skin Mass-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sleep Apnoea Syndrome-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Slow Speech-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Solar Lentigo-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Somnolence-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Speech Disorder-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spermatocele-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Compression Fracture-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Meningeal Cyst-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Spinal Osteoarthritis-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Squamous Cell Carcinoma-non-SAE-Mod	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Stress-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Suicide Attempt-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Sunburn-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swelling Face-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swelling Face-non-SAE-Sev	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Swollen Tongue-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Synovial Cyst-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tachycardia-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tachycardia-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendon Disorder-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendonitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tendonitis-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Testicular Microlithiasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Testicular Pain-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thermal Burn-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thinking Abnormal-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Thrombocytopenia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tibia Fracture-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tinea Cruris-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tinea Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Abscess-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Abscess-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Fracture-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Infection-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tooth Infection-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Toothache-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Toxicity To Various Agents-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tracheal Stenosis-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Transient Ischaemic Attack-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Traumatic Haematoma-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tricuspid Valve Incompetence-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Trigeminal Neuralgia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Tympanic Membrane Scarring-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Type 2 Diabetes Mellitus-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Limb Fracture-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Limb Fracture-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-Mild	0.010 Number of AEs per infusion	0.013 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper Respiratory Tract Infection-non-SAE-Mod	0.008 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Upper-Airway Cough Syndrome-non-SAE-Mild	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urethritis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urinary Tract Infection-non-SAE-Mild	0.003 Number of AEs per infusion	0.007 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urinary Tract Infection-non-SAE-Mod	0.004 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Urticaria-non-SAE-Mild	0 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Uterine Polyp-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vaginal Prolapse-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vaginitis Bacterial-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Varicose Vein-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vasomotor Rhinitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vein Pain-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Ventricular Hypokinesia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vessel Puncture Site Bruise-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Infection-non-SAE-Mild	0.002 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Infection-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Pharyngitis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Pharyngitis-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Rash-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Upper Respiratory Tract Inf.-non-SAE-Mild	0.018 Number of AEs per infusion	0.008 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Viral Upper Respiratory Tract Inf-non-SAE-Mod	0.001 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vision Blurred-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin B12 Deficiency-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Decreased-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Deficiency-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vitamin D Deficiency-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vomiting-non-SAE-Mild	0.008 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vomiting-non-SAE-Mod	0.003 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvar Dysplasia-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Candidiasis-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-Mild	0.003 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Vulvovaginal Mycotic Infection-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wheezing-non-SAE-Mod	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wisdom Teeth Removal-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wisdom Teeth Removal-non-SAE-Sev	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wound-non-SAE-Mild	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Wrist Fracture-non-SAE-Mod	0 Number of AEs per infusion	0.002 Number of AEs per infusion
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). Xeroderma-non-SAE-Mild	0.001 Number of AEs per infusion	0 Number of AEs per infusion

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
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") Total AEs, Mild	4.635 Number of AEs per participant	2.137 Number of AEs per participant
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") Total AEs, Moderate	0.476 Number of AEs per participant	0.392 Number of AEs per participant
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") Total AEs, Severe	0.016 Number of AEs per participant	0.059 Number of AEs per participant
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") Total AEs, Total	5.127 Number of AEs per participant	2.588 Number of AEs per participant
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") Local nsAEs, Mild	2.476 Number of AEs per participant	0.373 Number of AEs per participant
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") Local AEs, Moderate	0.111 Number of AEs per participant	0 Number of AEs per participant
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") Local AEs, Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
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") Local AEs, Total	2.603 Number of AEs per participant	0.373 Number of AEs per participant
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") Systemic AEs including infections, Mild	2.159 Number of AEs per participant	1.765 Number of AEs per participant
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") Systemic AEs including infections, Moderate	0.365 Number of AEs per participant	0.392 Number of AEs per participant
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") Systemic AEs including infections, Severe	0 Number of AEs per participant	0.059 Number of AEs per participant
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") Systemic AEs including infections, Total	2.524 Number of AEs per participant	2.216 Number of AEs per participant
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") Systemic AEs excluding infections, Mild	2.159 Number of AEs per participant	1.765 Number of AEs per participant
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") Systemic AEs excluding infections, Moderate	0.365 Number of AEs per participant	0.392 Number of AEs per participant
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") Systemic AEs excluding infections, Severe	0 Number of AEs per participant	0.059 Number of AEs per participant
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") Systemic AEs excluding infections, Total	2.524 Number of AEs per participant	2.216 Number of AEs per participant

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
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") Total AEs, Mild	0.183 Number of AEs per infusion	0.182 Number of AEs per infusion
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") Total AEs, Moderate	0.019 Number of AEs per infusion	0.033 Number of AEs per infusion
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") Total AEs, Severe	0.001 Number of AEs per infusion	0.005 Number of AEs per infusion
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") Total AEs, Total	0.202 Number of AEs per infusion	0.221 Number of AEs per infusion
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") Local AEs, Mild	0.098 Number of AEs per infusion	0.032 Number of AEs per infusion
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") Local AEs, Moderate	0.004 Number of AEs per infusion	0 Number of AEs per infusion
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") Local AEs, Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
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") Local AEs, Total	0.103 Number of AEs per infusion	0.032 Number of AEs per infusion
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") Systemic AEs including infections, Mild	0.085 Number of AEs per infusion	0.151 Number of AEs per infusion
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") Systemic AEs including infections, Moderate	0.014 Number of AEs per infusion	0.033 Number of AEs per infusion
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") Systemic AEs including infections, Severe	0 Number of AEs per infusion	0.005 Number of AEs per infusion
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") Systemic AEs including infections, Total	0.099 Number of AEs per infusion	0.189 Number of AEs per infusion
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") Systemic AEs excluding infections, Mild	0.085 Number of AEs per infusion	0.151 Number of AEs per infusion
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") Systemic AEs excluding infections, Moderate	0.014 Number of AEs per infusion	0.033 Number of AEs per infusion
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") Systemic AEs excluding infections, Severe	0 Number of AEs per infusion	0.005 Number of AEs per infusion
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") Systemic AEs excluding infections, Total	0.099 Number of AEs per infusion	0.189 Number of AEs per infusion

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=63 Participants 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 Participants 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%.
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, nsAE, Moderate	1.000 Number of AEs per participant	0.608 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, nsAE, Mild	5.921 Number of AEs per participant	2.275 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, nsAE, Moderate	1.111 Number of AEs per participant	0.647 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, nsAE, Severe	0.032 Number of AEs per participant	0.059 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total nsAE, Total	7.063 Number of AEs per participant	2.980 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Moderate	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Total	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Local, nsAE, Mild	2.492 Number of AEs per participant	0.353 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Local, nsAE, Moderate	0.111 Number of AEs per participant	0.039 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Local, nsAE, Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Local, nsAE, Total	2.619 Number of AEs per participant	0.392 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, nsAE, Mild	3.429 Number of AEs per participant	1.922 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, nsAE, Severe	0.016 Number of AEs per participant	0.059 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, nsAE, Total	4.444 Number of AEs per participant	2.588 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Moderate	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Total	0.032 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, nsAE, Mild	3.111 Number of AEs per participant	1.922 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, nsAE, Moderate	0.873 Number of AEs per participant	0.608 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, nsAE, Severe	0.016 Number of AEs per participant	0.059 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, nsAE, Total	4.000 Number of AEs per participant	2.588 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Moderate	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Severe	0.016 Number of AEs per participant	0 Number of AEs per participant
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Total	0.032 Number of AEs per participant	0 Number of AEs per participant

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Data Set

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.

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, non-SAE, Moderate	0.034 Number of AEs per infusion	0.043 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, non-SAE, Mild	0.233 Number of AEs per infusion	0.194 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, non-SAE, Moderate	0.044 Number of AEs per infusion	0.055 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, non-SAE, Severe	0.001 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total non-SAE, Total	0.278 Number of AEs per infusion	0.254 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Moderate	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Total, SAE, Total	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Local, non-SAE, Mild	0.098 Number of AEs per infusion	0.030 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Local, non-SAE, Moderate	0.004 Number of AEs per infusion	0.003 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Local, non-SAE, Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Local, non-SAE, Total	0.103 Number of AEs per infusion	0.033 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, non-SAE, Mild	0.135 Number of AEs per infusion	0.164 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, non-SAE, Moderate	0.039 Number of AEs per infusion	0.052 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, non-SAE, Severe	0.001 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, non-SAE, Total	0.175 Number of AEs per infusion	0.221 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Moderate	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic including infections, SAE, Total	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, non-SAE, Mild	0.123 Number of AEs per infusion	0.156 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, non-SAE, Severe	0.001 Number of AEs per infusion	0.005 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, non-SAE, Total	0.158 Number of AEs per infusion	0.204 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Moderate	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Severe	0.001 Number of AEs per infusion	0 Number of AEs per infusion
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion Systemic excluding infections, SAE, Total	0.001 Number of AEs per infusion	0 Number of AEs per infusion

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	All Participants Treated With IGSC, 10% and rHuPH20 n=1600 Infusions 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.	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=598 Infusions 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%.
Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study Including Infections	8.8 Percentage of infusions	3.7 Percentage of infusions
Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study Excluding Infections	8.7 Percentage of infusions	3.7 Percentage of infusions

Adverse Events

IGSC, 10% - rHuPH20

Serious events: 9 serious events

Other events: 60 other events

Deaths: 0 deaths

Safety Follow-up - IGSC, 10% or IGIV, 10% Only

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IGSC, 10% - rHuPH20 n=63 participants at risk Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 participants at risk 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%.
Cardiac disorders Aortic Valve Incompetence	1.6% 1/63 • Number of events 1	0.00% 0/51
Cardiac disorders Atrial Fibrillation	1.6% 1/63 • Number of events 1	0.00% 0/51
Cardiac disorders Cardiac Failure Congestive	1.6% 1/63 • Number of events 1	0.00% 0/51
Infections and infestations Appendicitis	1.6% 1/63 • Number of events 1	0.00% 0/51
Infections and infestations Cellulitis	0.00% 0/63	2.0% 1/51 • Number of events 1
Infections and infestations Cryptosporidiosis Infection	1.6% 1/63 • Number of events 1	0.00% 0/51
Infections and infestations Pneumonia Pseudomonas Aeruginosa	1.6% 1/63 • Number of events 1	0.00% 0/51
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/63	2.0% 1/51 • Number of events 1
Injury, poisoning and procedural complications Toxicity to Various Agents	1.6% 1/63 • Number of events 1	0.00% 0/51
Nervous system disorders Spinal Meningeal Cyst	1.6% 1/63 • Number of events 1	0.00% 0/51
Nervous system disorders Transient Ischaemic Attack	0.00% 0/63	2.0% 1/51 • Number of events 1
Psychiatric disorders Mental Status Changes	1.6% 1/63 • Number of events 1	0.00% 0/51
Reproductive system and breast disorders Cystocele	1.6% 1/63 • Number of events 1	0.00% 0/51
Reproductive system and breast disorders Vaginal Prolapse	1.6% 1/63 • Number of events 1	0.00% 0/51
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.6% 1/63 • Number of events 2	0.00% 0/51
Surgical and medical procedures Adhesiolysis	1.6% 1/63 • Number of events 1	0.00% 0/51
Vascular disorders Hypertension	1.6% 1/63 • Number of events 1	0.00% 0/51

Other adverse events

Other adverse events
Measure	IGSC, 10% - rHuPH20 n=63 participants at risk Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).	Safety Follow-up - IGSC, 10% or IGIV, 10% Only n=51 participants at risk 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%.
Blood and lymphatic system disorders Lymphadenopathy	7.9% 5/63 • Number of events 5	2.0% 1/51 • Number of events 2
Cardiac disorders Tachycardia	7.9% 5/63 • Number of events 6	2.0% 1/51 • Number of events 1
Gastrointestinal disorders Abdominal Pain	6.3% 4/63 • Number of events 7	3.9% 2/51 • Number of events 4
Gastrointestinal disorders Abdominal Pain Upper	11.1% 7/63 • Number of events 8	0.00% 0/51
Gastrointestinal disorders Apthous Stomatitis	6.3% 4/63 • Number of events 7	3.9% 2/51 • Number of events 2
Gastrointestinal disorders Constipation	9.5% 6/63 • Number of events 6	2.0% 1/51 • Number of events 3
Gastrointestinal disorders Diarrhoea	20.6% 13/63 • Number of events 19	5.9% 3/51 • Number of events 5
Gastrointestinal disorders Gastrooesophageal Reflux	6.3% 4/63 • Number of events 4	0.00% 0/51
Gastrointestinal disorders Nausea	25.4% 16/63 • Number of events 46	7.8% 4/51 • Number of events 25
Gastrointestinal disorders Vomiting	20.6% 13/63 • Number of events 17	3.9% 2/51 • Number of events 4
General disorders Asthenia	6.3% 4/63 • Number of events 16	2.0% 1/51 • Number of events 1
General disorders Fatigue	17.5% 11/63 • Number of events 27	9.8% 5/51 • Number of events 23
General disorders Infusion Site Discomfort	7.9% 5/63 • Number of events 8	2.0% 1/51 • Number of events 2
General disorders Infusion Site Erythema	19.0% 12/63 • Number of events 23	0.00% 0/51
General disorders Infusion site Pain	25.4% 16/63 • Number of events 84	3.9% 2/51 • Number of events 19
General disorders Infusion Site Pruritus	9.5% 6/63 • Number of events 31	0.00% 0/51
General disorders Oedema Peripheral	4.8% 3/63 • Number of events 8	11.8% 6/51 • Number of events 6
General disorders Pain	6.3% 4/63 • Number of events 9	0.00% 0/51
General disorders Pyrexia	15.9% 10/63 • Number of events 16	7.8% 4/51 • Number of events 5
Infections and infestations Bronchitis	22.2% 14/63 • Number of events 22	11.8% 6/51 • Number of events 7
Infections and infestations Cellulitis	6.3% 4/63 • Number of events 4	2.0% 1/51 • Number of events 1
Infections and infestations Chronic Sinusitis	7.9% 5/63 • Number of events 8	3.9% 2/51 • Number of events 3
Infections and infestations Gastroenteritis	7.9% 5/63 • Number of events 5	0.00% 0/51
Infections and infestations Gastroenteritis Viral	11.1% 7/63 • Number of events 7	3.9% 2/51 • Number of events 2
Infections and infestations Influenza	7.9% 5/63 • Number of events 6	7.8% 4/51 • Number of events 4
Infections and infestations Nasopharyngitis	9.5% 6/63 • Number of events 8	2.0% 1/51 • Number of events 5
Infections and infestations Oral Herpes	7.9% 5/63 • Number of events 7	3.9% 2/51 • Number of events 2
Infections and infestations Pharyngitis	7.9% 5/63 • Number of events 6	3.9% 2/51 • Number of events 2
Infections and infestations Sinusitis	39.7% 25/63 • Number of events 63	21.6% 11/51 • Number of events 16
Infections and infestations Upper Respiratory Tract Infection	28.6% 18/63 • Number of events 29	17.6% 9/51 • Number of events 10
Infections and infestations Urinary Tract Infection	7.9% 5/63 • Number of events 10	9.8% 5/51 • Number of events 6
Infections and infestations Viral Upper Respiratory Tract Infection	25.4% 16/63 • Number of events 30	5.9% 3/51 • Number of events 6
Injury, poisoning and procedural complications Contusion	0.00% 0/63	5.9% 3/51 • Number of events 3
Injury, poisoning and procedural complications Excoriation	12.7% 8/63 • Number of events 9	2.0% 1/51 • Number of events 1
Injury, poisoning and procedural complications Procedural Pain	12.7% 8/63 • Number of events 9	3.9% 2/51 • Number of events 2
Investigations Blood Creatine Phosphokinase Increased	6.3% 4/63 • Number of events 5	0.00% 0/51
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 7/63 • Number of events 8	9.8% 5/51 • Number of events 7
Musculoskeletal and connective tissue disorders Back Pain	6.3% 4/63 • Number of events 6	7.8% 4/51 • Number of events 5
Musculoskeletal and connective tissue disorders Myalgia	6.3% 4/63 • Number of events 28	5.9% 3/51 • Number of events 8
Nervous system disorders Dizziness	9.5% 6/63 • Number of events 11	2.0% 1/51 • Number of events 1
Nervous system disorders Headache	38.1% 24/63 • Number of events 47	19.6% 10/51 • Number of events 41
Nervous system disorders Migraine	9.5% 6/63 • Number of events 9	7.8% 4/51 • Number of events 8
Psychiatric disorders Anxiety	6.3% 4/63 • Number of events 4	0.00% 0/51
Psychiatric disorders Depression	6.3% 4/63 • Number of events 4	2.0% 1/51 • Number of events 1
Psychiatric disorders Insomnia	7.9% 5/63 • Number of events 5	2.0% 1/51 • Number of events 1
Respiratory, thoracic and mediastinal disorders Asthma	20.6% 13/63 • Number of events 32	11.8% 6/51 • Number of events 6
Respiratory, thoracic and mediastinal disorders Cough	15.9% 10/63 • Number of events 14	7.8% 4/51 • Number of events 4
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 4/63 • Number of events 4	2.0% 1/51 • Number of events 1
Respiratory, thoracic and mediastinal disorders Epistaxis	6.3% 4/63 • Number of events 11	5.9% 3/51 • Number of events 5
Respiratory, thoracic and mediastinal disorders Nasal Congestion	7.9% 5/63 • Number of events 13	3.9% 2/51 • Number of events 5
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.3% 4/63 • Number of events 4	2.0% 1/51 • Number of events 1
Skin and subcutaneous tissue disorders Dermititis Contact	6.3% 4/63 • Number of events 4	0.00% 0/51
Skin and subcutaneous tissue disorders Pruritus	4.8% 3/63 • Number of events 4	5.9% 3/51 • Number of events 6
Vascular disorders Hypertension	9.5% 6/63 • Number of events 7	2.0% 1/51 • Number of events 1

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxalta requires a review of results communications (e.g., for confidential information) ≥45 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
Publication restrictions are in place

Restriction type: OTHER