Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

• Sponsor: Baxalta now part of Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02556775
• Collaborator: Baxalta Innovations GmbH, now part of Shire (Industry)
• Enrollment: 16
• Locations: 8
• Actual Duration (Months): 48.4
• Patients Per Site: 2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be followed.

Condition or Disease	Intervention/Treatment	Phase
Exposure During Pregnancy	Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment; Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
• Actual Study Start Date: Dec 4, 2015
• Actual Primary Completion Date: Dec 17, 2019
• Actual Study Completion Date: Dec 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Alternative Product Arm Participant stops HYQVIA treatment (if the participant is still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment will be administered, as determined by the physician.	Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment; To be determined by the physician
HYQVIA Arm Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen.	Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]; Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase; Other Names: Hyqvia

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Serious Adverse Events (SAEs) [From start of study drug administration up to end of study (up to 48.4 months)]

   An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Number of participants with SAEs in expectant mothers and infants were reported.

Secondary Outcome Measures

1. Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment [From start of study drug administration up to end of study (up to 48.4 months)]

   An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with the treatment. Number of participants with Non-SAEs, related and not related to HyQvia/Human Normal IG or alternative treatment in expectant mothers and infants were reported.

2. Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers [From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)]

   AESI were AEs that were considered by the sponsor to be relevant for the monitoring of the safety profile. AESI's included in this study were local/immunologic AEs including skin changes (Such as, local erythema, local pruritus, induration, nodules). Number of participants with AESIs in expectant mother were reported.

3. Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers [From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)]

   Number of participants who developed positive [titer ≥160] of anti-rHuPH20 binding in expectant mothers were reported. Neutralizing antibodies were assessed if the binding antibody assay has a result of 160 or above.

4. Number of Participants With Antenatal Diagnostic Procedures [Throughout the expectant mother pregnancy duration (up to 40 weeks)]

   Antenatal diagnostic procedures included ultrasound, serology and nuchal translucency screen which are used to assess the Fetal growth/development. Number of participants reported fetal growth/development were recorded.

5. Number of Participants Who Experienced General Pregnancy Outcomes [Throughout the expectant mother pregnancy duration (up to 40 weeks)]

   Pregnancy outcomes included live birth, fetal death, termination or unknown.

6. Number of Participants With Neonatal Assessment [At or after delivery/end of pregnancy (up to 40 weeks)]

   Neonatal assessment included parameters like weight, length, head circumference, Apgar scores, pulse rate, blood pressure, respiratory rate, body temperature with normal, abnormal and missing status. The Apgar scores was determined by evaluating the newborn baby on five simple criteria: Appearance, Pulse, Grimace, Activity, Respiration: on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.

7. Number of Participants With Status of the Infant at Birth [At or after delivery/end of pregnancy (up to 40 weeks)]

   Status of the infant at birth included the following as: Any need for resuscitation of the infant, Admission in intensive care unit, Presence of congenital malformations/anomaly, Any other conditions noted at or around birth with status yes, no and unknown.

8. Number of Participants With Growth Measurement and Charts for the Infant [At 6, 12, 18 and 24 months follow-up]

   Growth measurement and charts for the infant was assessed based on following parameters: Any congenital malformations diagnosed that were not reported at birth, any conditions that were noted since birth, weight assessment, length assessment, head circumference assessment. Number of participants with growth measurement and charts for the infant at 6, 12, 18 and 24 months follow-up was reported.

9. Number of Participants With Development Milestones [At 6, 12, 18 and 24 months follow-up]

   Developmental milestones evaluation included rolled over, attended to and reached for objects, sat up without support, turned to locate a voice, said his/her first words, and stand without support/help. Number of participants with development milestones at 6, 12, 18 and 24 months follow-up was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• For the expectant mother only: Participant became pregnant during or after treatment with HYQVIA

• Participant/Participant's legally authorized representative is willing to sign an informed consent form (ICF)

Exclusion Criteria:

• There are no applicable Exclusion Criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QuintilesIMS Plaza Building	Durham	North Carolina	United States	27703
2	Fakultni nemocnice Kralovske Vinohrady	Praha 10		Czechia	10034
3	Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher	Freiburg	Baden-Württemberg	Germany	79108
4	Universitaetsklinikum Wuerzburg	Würzburg	Bayern	Germany	97080
5	Klinikum St. Georg GmbH	Leipzig	Sachsen	Germany	04129
6	Wojskowy Instytut Medyczny	Warszawa		Poland	04-141
7	Onkologicky ustav svatej Alzbety s.r.o.	Bratislava		Slovakia	81250
8	RAFMED s.r.o	Kosice		Slovakia	04001

Sponsors and Collaborators

• Baxalta now part of Shire
• Baxalta Innovations GmbH, now part of Shire

Investigators

• Study Director: Shire Director, Shire

Study Documents (Full-Text)

• Study Protocol - Oct 22, 2015
• Statistical Analysis Plan - Apr 2, 2020

More Information

Publications

None provided.

• Responsible Party: Baxalta now part of Shire
• ClinicalTrials.gov Identifier: NCT02556775
• Other Study ID Numbers: 161301; EUPAS5798
• First Posted: Sep 22, 2015
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin

Study Results

Participant Flow

Recruitment Details

This study was conducted at 8 centers in Czech Republic, Germany, Poland, Slovakia, and United States of America from 04 December 2015 (first participant first visit) to 17 December 2019 (last participant last visit).

Pre-assignment Detail

Total 16 participants (9 mothers and 7 infants) were enrolled in the study. Of 9 mothers, 7 included in Retrospective (R) cohort and 2 in Prospective (P) cohort. Of 7 infants enrolled from 9 mothers (1 mother lost to follow-up; another mother withdrew consent prior to delivery) of R cohort; 5 included in R cohort and 2 included in P cohort. Study consisted of Study Arm1 (Alternative Product Arm) and Study Arm2 (HyQvia Arm). All participants were analyzed according to type of enrollment R and P.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Period Title: Overall Study
STARTED	7	2	5	2
COMPLETED	5	2	4	2
NOT COMPLETED	2	0	1	0

Baseline Characteristics

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers	Retrospective Cohort: Infants	Prospective Cohort: Infants	Total
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.	Total of all reporting groups
Overall Participants	7	2	5	2	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	5 100%	2 100%	7 43.8%
Between 18 and 65 years	7 100%	2 100%	0 0%	0 0%	9 56.3%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	2 100%	2 40%	2 100%	13 81.3%
Male	0 0%	0 0%	3 60%	0 0%	3 18.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 50%	0 0%	0 0%	1 6.3%
Not Hispanic or Latino	7 100%	1 50%	5 100%	2 100%	15 93.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	7 100%	2 100%	5 100%	2 100%	16 100%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Number of participants with SAEs in expectant mothers and infants were reported.
Time Frame	From start of study drug administration up to end of study (up to 48.4 months)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	7	2	5	2
Count of Participants [Participants]	0 0%	1 50%	1 20%	1 50%

2. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Description	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with the treatment. Number of participants with Non-SAEs, related and not related to HyQvia/Human Normal IG or alternative treatment in expectant mothers and infants were reported.
Time Frame	From start of study drug administration up to end of study (up to 48.4 months)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	7	2	5	2
Participants with Non-SAEs	2 28.6%	2 100%	4 80%	1 50%
Participants with AE related to human normal immunoglobulin treatment	0 0%	0 0%	0 0%	0 0%
Participants with AE related to HyQvia	0 0%	0 0%	0 0%	0 0%
Participants with AE related to alternative treatment	0 0%	0 0%	0 0%	0 0%
Participants: AE not related to HyQvia/human normal immunoglobulin treatment/alternative treatment	2 28.6%	2 100%	4 80%	2 100%

3. Secondary Outcome

Title	Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers
Description	AESI were AEs that were considered by the sponsor to be relevant for the monitoring of the safety profile. AESI's included in this study were local/immunologic AEs including skin changes (Such as, local erythema, local pruritus, induration, nodules). Number of participants with AESIs in expectant mother were reported.
Time Frame	From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	7	2
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers
Description	Number of participants who developed positive [titer ≥160] of anti-rHuPH20 binding in expectant mothers were reported. Neutralizing antibodies were assessed if the binding antibody assay has a result of 160 or above.
Time Frame	From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	3	1
Anti-rHuPH20 binding antibody : Positive	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Antenatal Diagnostic Procedures
Description	Antenatal diagnostic procedures included ultrasound, serology and nuchal translucency screen which are used to assess the Fetal growth/development. Number of participants reported fetal growth/development were recorded.
Time Frame	Throughout the expectant mother pregnancy duration (up to 40 weeks)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	7	2
Ultrasound	3 42.9%	0 0%
Serology	2 28.6%	0 0%
Nuchal Translucency Screen	1 14.3%	0 0%

6. Secondary Outcome

Title	Number of Participants Who Experienced General Pregnancy Outcomes
Description	Pregnancy outcomes included live birth, fetal death, termination or unknown.
Time Frame	Throughout the expectant mother pregnancy duration (up to 40 weeks)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group.

Arm/Group Title	Retrospective Cohort: Expectant Mothers	Prospective Cohort: Expectant Mothers
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	7	2
Live Birth	6 85.7%	2 100%
Fetal Death	0 0%	0 0%
Termination	0 0%	0 0%
Missing	1 14.3%	0 0%

7. Secondary Outcome

Title	Number of Participants With Neonatal Assessment
Description	Neonatal assessment included parameters like weight, length, head circumference, Apgar scores, pulse rate, blood pressure, respiratory rate, body temperature with normal, abnormal and missing status. The Apgar scores was determined by evaluating the newborn baby on five simple criteria: Appearance, Pulse, Grimace, Activity, Respiration: on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.
Time Frame	At or after delivery/end of pregnancy (up to 40 weeks)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers.

Arm/Group Title	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	5	2
Weight: Normal	5 71.4%	2 100%
Weight: Abnormal	0 0%	0 0%
Weight: Missing	0 0%	0 0%
Length: Normal	5 71.4%	1 50%
Length: Abnormal	0 0%	0 0%
Length: Missing	0 0%	1 50%
Head circumference: Normal	4 57.1%	0 0%
Head circumference: Abnormal	0 0%	0 0%
Head circumference: Missing	1 14.3%	2 100%
Apgar scores: Normal	5 71.4%	2 100%
Apgar scores: Abnormal	0 0%	0 0%
Apgar scores: Missing	0 0%	0 0%
Pulse rate: Normal	0 0%	0 0%
Pulse rate: Abnormal	0 0%	0 0%
Pulse rate: Missing	5 71.4%	2 100%
Blood pressure: Normal	0 0%	0 0%
Blood pressure: Abnormal	0 0%	0 0%
Blood pressure: Missing	5 71.4%	2 100%
Respiratory rate: Normal	0 0%	0 0%
Respiratory rate: Abnormal	0 0%	0 0%
Respiratory rate: Missing	5 71.4%	2 100%
Body temperature: Normal	0 0%	0 0%
Body temperature: Abnormal	0 0%	0 0%
Body temperature: Missing	5 71.4%	2 100%

8. Secondary Outcome

Title	Number of Participants With Status of the Infant at Birth
Description	Status of the infant at birth included the following as: Any need for resuscitation of the infant, Admission in intensive care unit, Presence of congenital malformations/anomaly, Any other conditions noted at or around birth with status yes, no and unknown.
Time Frame	At or after delivery/end of pregnancy (up to 40 weeks)

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers.

Arm/Group Title	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	5	2
Any need for resuscitation of the infant: Yes	0 0%	0 0%
Any need for resuscitation of the infant: No	5 71.4%	2 100%
Any need for resuscitation of the infant: Unknown	0 0%	0 0%
Admission in intensive care unit: Yes	0 0%	0 0%
Admission in intensive care unit: No	5 71.4%	2 100%
Admission in intensive care unit: Unknown	0 0%	0 0%
Presence of congenital malformations/anomaly: Yes	1 14.3%	1 50%
Presence of congenital malformations/anomaly: No	4 57.1%	1 50%
Presence of congenital malformations/anomaly: Unknown	0 0%	0 0%
Any other conditions noted at or around birth: Yes	0 0%	0 0%
Any other conditions noted at or around birth: No	5 71.4%	2 100%
Any other conditions noted at or around birth: Unknown	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Growth Measurement and Charts for the Infant
Description	Growth measurement and charts for the infant was assessed based on following parameters: Any congenital malformations diagnosed that were not reported at birth, any conditions that were noted since birth, weight assessment, length assessment, head circumference assessment. Number of participants with growth measurement and charts for the infant at 6, 12, 18 and 24 months follow-up was reported.
Time Frame	At 6, 12, 18 and 24 months follow-up

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers.

Arm/Group Title	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	5	2
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes	0 0%	0 0%
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No	1 14.3%	1 50%
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown	0 0%	0 0%
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing	4 57.1%	1 50%
6 months follow-up: Any conditions that were noted since birth: Yes	0 0%	0 0%
6 months follow-up: Any conditions that were noted since birth: No	1 14.3%	1 50%
6 months follow-up: Any conditions that were noted since birth: Unknown	0 0%	0 0%
6 months follow-up: Any conditions that were noted since birth: Missing	4 57.1%	1 50%
6 months follow-up: Weight assessment: Normal	1 14.3%	2 100%
6 months follow-up: Weight assessment: Abnormal and clinically significant	0 0%	0 0%
6 months follow-up: Weight assessment: Abnormal but not clinically significant	0 0%	0 0%
6 months follow-up: Weight assessment: Missing	4 57.1%	0 0%
6 months follow-up: Length assessment: Normal	1 14.3%	1 50%
6 months follow-up: Length assessment: Abnormal and clinically significant	0 0%	0 0%
6 months follow-up: Length assessment: Abnormal but not clinically significant	0 0%	0 0%
6 months follow-up: Length assessment: Missing	4 57.1%	1 50%
6 months follow-up: Head circumference assessment: Normal	1 14.3%	1 50%
6 months follow-up: Head circumference assessment: Abnormal and clinically significant	0 0%	0 0%
6 months follow-up: Head circumference assessment: Abnormal but not clinically significant	0 0%	0 0%
6 months follow-up: Head circumference assessment: Missing	4 57.1%	1 50%
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes	0 0%	0 0%
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No	0 0%	1 50%
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown	0 0%	0 0%
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing	5 71.4%	1 50%
12 months follow-up: Any conditions that were noted since birth: Yes	0 0%	0 0%
12 months follow-up: Any conditions that were noted since birth: No	0 0%	1 50%
12 months follow-up: Any conditions that were noted since birth: Unknown	0 0%	0 0%
12 months follow-up: Any conditions that were noted since birth: Missing	5 71.4%	1 50%
12 months follow-up: Weight assessment: Normal	1 14.3%	1 50%
12 months follow-up: Weight assessment: Abnormal and clinically significant	0 0%	0 0%
12 months follow-up: Weight assessment: Abnormal but not clinically significant	0 0%	0 0%
12 months follow-up: Weight assessment: Missing	4 57.1%	1 50%
12 months follow-up: Length assessment: Normal	1 14.3%	1 50%
12 months follow-up: Length assessment: Abnormal and clinically significant	0 0%	0 0%
12 months follow-up: Length assessment: Abnormal but not clinically significant	0 0%	0 0%
12 months follow-up: Length assessment: Missing	4 57.1%	1 50%
12 months follow-up: Head circumference assessment: Normal	1 14.3%	1 50%
12 months follow-up: Head circumference assessment: Abnormal and clinically significant	0 0%	0 0%
12 months follow-up: Head circumference assessment: Abnormal but not clinically significant	0 0%	0 0%
12 months follow-up: Head circumference assessment: Missing	4 57.1%	1 50%
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes	0 0%	0 0%
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No	1 14.3%	0 0%
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown	0 0%	0 0%
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing	4 57.1%	2 100%
18 months follow-up: Any conditions that were noted since birth: Yes	1 14.3%	0 0%
18 months follow-up: Any conditions that were noted since birth: No	0 0%	0 0%
18 months follow-up: Any conditions that were noted since birth: Unknown	0 0%	0 0%
18 months follow-up: Any conditions that were noted since birth: Missing	4 57.1%	2 100%
18 months follow-up: Weight assessment: Normal	1 14.3%	0 0%
18 months follow-up: Weight assessment: Abnormal and clinically significant	0 0%	0 0%
18 months follow-up: Weight assessment: Abnormal but not clinically significant	0 0%	0 0%
18 months follow-up: Weight assessment: Missing	4 57.1%	2 100%
18 months follow-up: Length assessment: Normal	1 14.3%	0 0%
18 months follow-up: Length assessment: Abnormal and clinically significant	0 0%	0 0%
18 months follow-up: Length assessment: Abnormal but not clinically significant	0 0%	0 0%
18 months follow-up: Length assessment: Missing	4 57.1%	2 100%
18 months follow-up: Head circumference assessment: Normal	1 14.3%	0 0%
18 months follow-up: Head circumference assessment: Abnormal and clinically significant	0 0%	0 0%
18 months follow-up: Head circumference assessment: Abnormal but not clinically significant	0 0%	0 0%
18 months follow-up: Head circumference assessment: Missing	4 57.1%	2 100%
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes	0 0%	0 0%
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No	1 14.3%	1 50%
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown	0 0%	0 0%
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing	4 57.1%	1 50%
24 months follow-up: Any conditions that were noted since birth: Yes	0 0%	0 0%
24 months follow-up: Any conditions that were noted since birth: No	1 14.3%	1 50%
24 months follow-up: Any conditions that were noted since birth: Unknown	0 0%	0 0%
24 months follow-up: Any conditions that were noted since birth: Missing	4 57.1%	1 50%
24 months follow-up: Weight assessment: Normal	0 0%	1 50%
24 months follow-up: Weight assessment: Abnormal and clinically significant	0 0%	0 0%
24 months follow-up: Weight assessment: Abnormal but not clinically significant	0 0%	0 0%
24 months follow-up: Weight assessment: Missing	5 71.4%	1 50%
24 months follow-up: Length assessment: Normal	0 0%	1 50%
24 months follow-up: Length assessment: Abnormal and clinically significant	0 0%	0 0%
24 months follow-up: Length assessment: Abnormal but not clinically significant	0 0%	0 0%
24 months follow-up: Length assessment: Missing	5 71.4%	1 50%
24 months follow-up: Head circumference assessment: Normal	0 0%	1 50%
24 months follow-up: Head circumference assessment: Abnormal and clinically significant	0 0%	0 0%
24 months follow-up: Head circumference assessment: Abnormal but not clinically significant	0 0%	0 0%
24 months follow-up: Head circumference assessment: Missing	5 71.4%	1 50%

10. Secondary Outcome

Title	Number of Participants With Development Milestones
Description	Developmental milestones evaluation included rolled over, attended to and reached for objects, sat up without support, turned to locate a voice, said his/her first words, and stand without support/help. Number of participants with development milestones at 6, 12, 18 and 24 months follow-up was reported.
Time Frame	At 6, 12, 18 and 24 months follow-up

Outcome Measure Data

Analysis Population Description

Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers.

Arm/Group Title	Retrospective Cohort: Infants	Prospective Cohort: Infants
Arm/Group Description	Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.	Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
Measure Participants	5	2
6 months follow-up: Rolled over: Not applicable yet	0 0%	0 0%
6 months follow-up: Rolled over: Milestone reached	1 14.3%	1 50%
6 months follow-up: Rolled over: Milestone missed	0 0%	0 0%
6 months follow-up: Rolled over: Unknown	0 0%	0 0%
6 months follow-up: Rolled over: Missing	4 57.1%	1 50%
6 months follow-up: Attended to and reached for objects: Not applicable yet	0 0%	0 0%
6 months follow-up: Attended to and reached for objects: Milestone reached	1 14.3%	1 50%
6 months follow-up: Attended to and reached for objects: Milestone missed	0 0%	0 0%
6 months follow-up: Attended to and reached for objects: Unknown	0 0%	0 0%
6 months follow-up: Attended to and reached for objects: Missing	4 57.1%	1 50%
6 months follow-up: Sat up without support: Not applicable yet	1 14.3%	0 0%
6 months follow-up: Sat up without support: Milestone reached	0 0%	1 50%
6 months follow-up: Sat up without support: Milestone missed	0 0%	0 0%
6 months follow-up: Sat up without support: Unknown	0 0%	0 0%
6 months follow-up: Sat up without support: Missing	4 57.1%	1 50%
6 months follow-up: Turned to locate a voice: Not applicable yet	0 0%	0 0%
6 months follow-up: Turned to locate a voice: Milestone reached	1 14.3%	1 50%
6 months follow-up: Turned to locate a voice: Milestone missed	0 0%	0 0%
6 months follow-up: Turned to locate a voice: Unknown	0 0%	0 0%
6 months follow-up: Turned to locate a voice: Missing	4 57.1%	1 50%
6 months follow-up: Said his/her first words: Not applicable yet	1 14.3%	1 50%
6 months follow-up: Said his/her first words: Milestone reached	0 0%	0 0%
6 months follow-up: Said his/her first words: Milestone missed	0 0%	0 0%
6 months follow-up: Said his/her first words: Unknown	0 0%	0 0%
6 months follow-up: Said his/her first words: Missing	4 57.1%	1 50%
6 months follow-up: Stand without support/help: Not applicable yet	1 14.3%	1 50%
6 months follow-up: Stand without support/help: Milestone reached	0 0%	0 0%
6 months follow-up: Stand without support/help: Milestone missed	0 0%	0 0%
6 months follow-up: Stand without support/help: Unknown	0 0%	0 0%
6 months follow-up: Stand without support/help: Missing	4 57.1%	1 50%
12 months follow-up: Rolled over: Not applicable yet	0 0%	0 0%
12 months follow-up: Rolled over: Milestone reached	0 0%	0 0%
12 months follow-up: Rolled over: Milestone missed	0 0%	0 0%
12 months follow-up: Rolled over: Unknown	0 0%	1 50%
12 months follow-up: Rolled over: Missing	5 71.4%	1 50%
12 months follow-up: Attended to and reached for objects: Not applicable yet	0 0%	0 0%
12 months follow-up: Attended to and reached for objects: Milestone reached	0 0%	0 0%
12 months follow-up: Attended to and reached for objects: Milestone missed	0 0%	0 0%
12 months follow-up: Attended to and reached for objects: Unknown	0 0%	1 50%
12 months follow-up: Attended to and reached for objects: Missing	5 71.4%	1 50%
12 months follow-up: Sat up without support: Not applicable yet	0 0%	0 0%
12 months follow-up: Sat up without support: Milestone reached	0 0%	0 0%
12 months follow-up: Sat up without support: Milestone missed	0 0%	0 0%
12 months follow-up: Sat up without support: Unknown	0 0%	1 50%
12 months follow-up: Sat up without support: Missing	5 71.4%	1 50%
12 months follow-up: Turned to locate a voice: Not applicable yet	0 0%	0 0%
12 months follow-up: Turned to locate a voice: Milestone reached	0 0%	0 0%
12 months follow-up: Turned to locate a voice: Milestone missed	0 0%	0 0%
12 months follow-up: Turned to locate a voice: Unknown	0 0%	1 50%
12 months follow-up: Turned to locate a voice: Missing	5 71.4%	1 50%
12 months follow-up: Said his/her first words: Not applicable yet	0 0%	0 0%
12 months follow-up: Said his/her first words: Milestone reached	0 0%	0 0%
12 months follow-up: Said his/her first words: Milestone missed	0 0%	0 0%
12 months follow-up: Said his/her first words: Unknown	0 0%	1 50%
12 months follow-up: Said his/her first words: Missing	5 71.4%	1 50%
12 months follow-up: Stand without support/help: Not applicable yet	0 0%	0 0%
12 months follow-up: Stand without support/help: Milestone reached	0 0%	0 0%
12 months follow-up: Stand without support/help: Milestone missed	0 0%	0 0%
12 months follow-up: Stand without support/help: Unknown	0 0%	0 0%
12 months follow-up: Stand without support/help: Missing	5 71.4%	2 100%
18 months follow-up: Rolled over: Not applicable ye	0 0%	0 0%
18 months follow-up: Rolled over: Milestone reached	1 14.3%	0 0%
18 months follow-up: Rolled over: Milestone missed	0 0%	0 0%
18 months follow-up: Rolled over: Unknown	0 0%	0 0%
18 months follow-up: Rolled over: Missing	4 57.1%	2 100%
18 months follow-up: Attended to and reached for objects: Not applicable yet	0 0%	0 0%
18 months follow-up: Attended to and reached for objects: Milestone reached	1 14.3%	0 0%
18 months follow-up: Attended to and reached for objects: Milestone missed	0 0%	0 0%
18 months follow-up: Attended to and reached for objects: Unknown	0 0%	0 0%
18 months follow-up: Attended to and reached for objects: Missing	4 57.1%	2 100%
18 months follow-up: Sat up without support: Not applicable yet	0 0%	0 0%
18 months follow-up: Sat up without support: Milestone reached	1 14.3%	0 0%
18 months follow-up: Sat up without support: Milestone missed	0 0%	0 0%
18 months follow-up: Sat up without support: Unknown	0 0%	0 0%
18 months follow-up: Sat up without support: Missing	4 57.1%	2 100%
18 months follow-up: Turned to locate a voice: Not applicable yet	0 0%	0 0%
18 months follow-up: Turned to locate a voice: Milestone reached	1 14.3%	0 0%
18 months follow-up: Turned to locate a voice: Milestone missed	0 0%	0 0%
18 months follow-up: Turned to locate a voice: Unknown	0 0%	0 0%
18 months follow-up: Turned to locate a voice: Missing	4 57.1%	2 100%
18 months follow-up: Said his/her first words: Not applicable yet	0 0%	0 0%
18 months follow-up: Said his/her first words: Milestone reached	1 14.3%	0 0%
18 months follow-up: Said his/her first words: Milestone missed	0 0%	0 0%
18 months follow-up: Said his/her first words: Unknown	0 0%	0 0%
18 months follow-up: Said his/her first words: Missing	4 57.1%	2 100%
18 months follow-up: Stand without support/help: Not applicable yet	0 0%	0 0%
18 months follow-up: Stand without support/help: Milestone reached	1 14.3%	0 0%
18 months follow-up: Stand without support/help: Milestone missed	0 0%	0 0%
18 months follow-up: Stand without support/help: Unknown	0 0%	0 0%
18 months follow-up: Stand without support/help: Missing	4 57.1%	2 100%
24 months follow-up: Rolled over: Not applicable yet	0 0%	0 0%
24 months follow-up: Rolled over: Milestone reached	0 0%	1 50%
24 months follow-up: Rolled over: Milestone missed	0 0%	0 0%
24 months follow-up: Rolled over: Unknown	1 14.3%	0 0%
24 months follow-up: Rolled over: Missing	4 57.1%	1 50%
24 months follow-up: Attended to and reached for objects: Not applicable yet	0 0%	0 0%
24 months follow-up: Attended to and reached for objects: Milestone reached	0 0%	1 50%
24 months follow-up: Attended to and reached for objects: Milestone missed	0 0%	0 0%
24 months follow-up: Attended to and reached for objects: Unknown	1 14.3%	0 0%
24 months follow-up: Attended to and reached for objects: Missing	4 57.1%	1 50%
24 months follow-up: Sat up without support: Not applicable yet	0 0%	0 0%
24 months follow-up: Sat up without support: Milestone reached	1 14.3%	1 50%
24 months follow-up: Sat up without support: Milestone missed	0 0%	0 0%
24 months follow-up: Sat up without support: Unknown	0 0%	0 0%
24 months follow-up: Sat up without support: Missing	4 57.1%	1 50%
24 months follow-up: Turned to locate a voice: Not applicable yet	0 0%	0 0%
24 months follow-up: Turned to locate a voice: Milestone reached	1 14.3%	1 50%
24 months follow-up: Turned to locate a voice: Milestone missed	0 0%	0 0%
24 months follow-up: Turned to locate a voice: Unknown	0 0%	0 0%
24 months follow-up: Turned to locate a voice: Missing	4 57.1%	1 50%
24 months follow-up: Said his/her first words: Not applicable yet	0 0%	0 0%
24 months follow-up: Said his/her first words: Milestone reached	0 0%	1 50%
24 months follow-up: Said his/her first words: Milestone missed	0 0%	0 0%
24 months follow-up: Said his/her first words: Unknown	1 14.3%	0 0%
24 months follow-up: Said his/her first words: Missing	4 57.1%	1 50%
24 months follow-up: Stand without support/help: Not applicable yet	0 0%	0 0%
24 months follow-up: Stand without support/help: Milestone reached	1 14.3%	1 50%
24 months follow-up: Stand without support/help: Milestone missed	0 0%	0 0%
24 months follow-up: Stand without support/help: Unknown	0 0%	0 0%
24 months follow-up: Stand without support/help: Missing	4 57.1%	1 50%

Adverse Events

Time Frame	From start of study drug administration up to end of study (up to 48.4 months)
Arm/Group Title	Retrospective Cohort: Expectant Mothers		Prospective Cohort: Expectant Mothers		Retrospective Cohort: Infants		Prospective Cohort: Infants
Arm/Group Description	Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.		Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.		Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment.		Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
All Cause Mortality
	Retrospective Cohort: Expectant Mothers		Prospective Cohort: Expectant Mothers		Retrospective Cohort: Infants		Prospective Cohort: Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/2 (0%)		0/5 (0%)		0/2 (0%)
Serious Adverse Events
	Retrospective Cohort: Expectant Mothers		Prospective Cohort: Expectant Mothers		Retrospective Cohort: Infants		Prospective Cohort: Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		1/2 (50%)		1/5 (20%)		1/2 (50%)
Blood and lymphatic system disorders
Thrombocytopenia	0/7 (0%)	0	1/2 (50%)	1	0/5 (0%)	0	0/2 (0%)	0
Congenital, familial and genetic disorders
Cleft lip	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Talipes	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia	0/7 (0%)	0	1/2 (50%)	1	0/5 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Retrospective Cohort: Expectant Mothers		Prospective Cohort: Expectant Mothers		Retrospective Cohort: Infants		Prospective Cohort: Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		2/2 (100%)		4/5 (80%)		1/2 (50%)
Blood and lymphatic system disorders
Anaemia of pregnancy	0/7 (0%)	0	2/2 (100%)	2	0/5 (0%)	0	0/2 (0%)	0
Neutropenia	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Eye disorders
Dacryostenosis acquired	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Gastrointestinal disorders
Diarrhoea	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Hepatobiliary disorders
Jaundice	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Infections and infestations
Bronchitis	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Genital herpes simplex	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Influenza	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Laryngitis	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Otitis media	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Pharyngitis	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Rhinitis	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Upper respiratory tract infection	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Urinary tract infection	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Fall	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Head injury	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Investigations
Hepatic enzyme increased	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Weight decreased	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Metabolism and nutrition disorders
Lactose intolerance	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	1/7 (14.3%)	1	0/2 (0%)	0	0/5 (0%)	0	0/2 (0%)	0
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal	0/7 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	1/2 (50%)	1
Pre-eclampsia	0/7 (0%)	0	1/2 (50%)	1	0/5 (0%)	0	0/2 (0%)	0
Uterine contractions during pregnancy	0/7 (0%)	0	1/2 (50%)	1	0/5 (0%)	0	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis atopic	0/7 (0%)	0	0/2 (0%)	0	1/5 (20%)	1	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.