Trial Outcomes & Findings for Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia (NCT NCT02556775)
NCT ID: NCT02556775
Last Updated: 2021-04-28
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
16 participants
Primary outcome timeframe
From start of study drug administration up to end of study (up to 48.4 months)
Results posted on
2021-04-28
Participant Flow
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).
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.
Participant milestones
| Measure |
Retrospective Cohort: Expectant Mothers
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.
|
Prospective Cohort: Expectant Mothers
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Retrospective Cohort: Expectant Mothers
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.
|
Prospective Cohort: Expectant Mothers
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Baseline characteristics by cohort
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
n=5 Participants
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.
|
Prospective Cohort: Infants
n=2 Participants
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
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to end of study (up to 48.4 months)Population: Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
n=5 Participants
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.
|
Prospective Cohort: Infants
n=2 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to end of study (up to 48.4 months)Population: Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
n=5 Participants
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.
|
Prospective Cohort: Infants
n=2 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Participants with Non-SAEs
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Participants with AE related to human normal immunoglobulin treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Participants with AE related to HyQvia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Participants with AE related to alternative treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Participants: AE not related to HyQvia/human normal immunoglobulin treatment/alternative treatment
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)Population: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)Population: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=3 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=1 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers
Anti-rHuPH20 binding antibody : Positive
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the expectant mother pregnancy duration (up to 40 weeks)Population: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Antenatal Diagnostic Procedures
Ultrasound
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Antenatal Diagnostic Procedures
Serology
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Antenatal Diagnostic Procedures
Nuchal Translucency Screen
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the expectant mother pregnancy duration (up to 40 weeks)Population: 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.
Pregnancy outcomes included live birth, fetal death, termination or unknown.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced General Pregnancy Outcomes
Live Birth
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Who Experienced General Pregnancy Outcomes
Fetal Death
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Experienced General Pregnancy Outcomes
Termination
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Experienced General Pregnancy Outcomes
Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At or after delivery/end of pregnancy (up to 40 weeks)Population: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=5 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Neonatal Assessment
Weight: Normal
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Weight: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Weight: Missing
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Length: Normal
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Length: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Length: Missing
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Head circumference: Normal
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Head circumference: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Head circumference: Missing
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Apgar scores: Normal
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Apgar scores: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Apgar scores: Missing
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Pulse rate: Normal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Pulse rate: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Pulse rate: Missing
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Blood pressure: Normal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Blood pressure: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Blood pressure: Missing
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Respiratory rate: Normal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Respiratory rate: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Respiratory rate: Missing
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Body temperature: Normal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Body temperature: Abnormal
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Neonatal Assessment
Body temperature: Missing
|
5 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At or after delivery/end of pregnancy (up to 40 weeks)Population: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=5 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Status of the Infant at Birth
Any need for resuscitation of the infant: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Any need for resuscitation of the infant: No
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Any need for resuscitation of the infant: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Admission in intensive care unit: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Admission in intensive care unit: No
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Admission in intensive care unit: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Presence of congenital malformations/anomaly: Yes
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Presence of congenital malformations/anomaly: No
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Presence of congenital malformations/anomaly: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Any other conditions noted at or around birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Any other conditions noted at or around birth: No
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Status of the Infant at Birth
Any other conditions noted at or around birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6, 12, 18 and 24 months follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=5 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Head circumference assessment: Normal
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any conditions that were noted since birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any conditions that were noted since birth: No
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any conditions that were noted since birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Any conditions that were noted since birth: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Weight assessment: Normal
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Weight assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Weight assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Weight assessment: Missing
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Length assessment: Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Length assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Length assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Length assessment: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Head circumference assessment: Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Head circumference assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Head circumference assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
6 months follow-up: Head circumference assessment: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any conditions that were noted since birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any conditions that were noted since birth: No
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any conditions that were noted since birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Any conditions that were noted since birth: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Weight assessment: Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Weight assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Weight assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Weight assessment: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Length assessment: Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Length assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Length assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Length assessment: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Head circumference assessment: Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Head circumference assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Head circumference assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
12 months follow-up: Head circumference assessment: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any conditions that were noted since birth: Yes
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any conditions that were noted since birth: No
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any conditions that were noted since birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Any conditions that were noted since birth: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Weight assessment: Normal
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Weight assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Weight assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Weight assessment: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Length assessment: Normal
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Length assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Length assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Length assessment: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Head circumference assessment: Normal
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Head circumference assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Head circumference assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
18 months follow-up: Head circumference assessment: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: No
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any congenital malformations diagnosed that were not reported at birth: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any conditions that were noted since birth: Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any conditions that were noted since birth: No
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any conditions that were noted since birth: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Any conditions that were noted since birth: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Weight assessment: Normal
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Weight assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Weight assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Weight assessment: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Length assessment: Normal
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Length assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Length assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Length assessment: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Head circumference assessment: Abnormal and clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Head circumference assessment: Abnormal but not clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Growth Measurement and Charts for the Infant
24 months follow-up: Head circumference assessment: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6, 12, 18 and 24 months follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Retrospective Cohort: Expectant Mothers
n=5 Participants
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.
|
Prospective Cohort: Expectant Mothers
n=2 Participants
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.
|
Retrospective Cohort: Infants
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.
|
Prospective Cohort: Infants
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.
|
|---|---|---|---|---|
|
Number of Participants With Development Milestones
6 months follow-up: Stand without support/help: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Attended to and reached for objects: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Turned to locate a voice: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Said his/her first words: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Said his/her first words: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Attended to and reached for objects: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Attended to and reached for objects: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Attended to and reached for objects: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Sat up without support: Not applicable yet
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Sat up without support: Milestone reached
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Sat up without support: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Sat up without support: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Sat up without support: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Turned to locate a voice: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Turned to locate a voice: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Turned to locate a voice: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Turned to locate a voice: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Turned to locate a voice: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Said his/her first words: Not applicable yet
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Said his/her first words: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Said his/her first words: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Said his/her first words: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Said his/her first words: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Stand without support/help: Not applicable yet
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Stand without support/help: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Stand without support/help: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Stand without support/help: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Rolled over: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Rolled over: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Rolled over: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Rolled over: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Rolled over: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Attended to and reached for objects: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Attended to and reached for objects: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Attended to and reached for objects: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Attended to and reached for objects: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Attended to and reached for objects: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Rolled over: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Sat up without support: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Rolled over: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Sat up without support: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Sat up without support: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Sat up without support: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Rolled over: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Rolled over: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Sat up without support: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Rolled over: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
6 months follow-up: Attended to and reached for objects: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Turned to locate a voice: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Turned to locate a voice: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Turned to locate a voice: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Turned to locate a voice: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Turned to locate a voice: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Turned to locate a voice: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Turned to locate a voice: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Turned to locate a voice: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Said his/her first words: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Said his/her first words: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Said his/her first words: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Said his/her first words: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Said his/her first words: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Said his/her first words: Missing
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Stand without support/help: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Stand without support/help: Milestone reached
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Stand without support/help: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Stand without support/help: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
12 months follow-up: Stand without support/help: Missing
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Rolled over: Not applicable ye
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Rolled over: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Said his/her first words: Milestone reached
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Said his/her first words: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Rolled over: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Said his/her first words: Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Rolled over: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Rolled over: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Attended to and reached for objects: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Attended to and reached for objects: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Attended to and reached for objects: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Attended to and reached for objects: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Attended to and reached for objects: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Sat up without support: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Sat up without support: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Sat up without support: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Sat up without support: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Sat up without support: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Turned to locate a voice: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Turned to locate a voice: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Turned to locate a voice: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Turned to locate a voice: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Said his/her first words: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Stand without support/help: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Stand without support/help: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Stand without support/help: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Stand without support/help: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Stand without support/help: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Said his/her first words: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Said his/her first words: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Said his/her first words: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Stand without support/help: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Stand without support/help: Milestone reached
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Stand without support/help: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Stand without support/help: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
18 months follow-up: Stand without support/help: Missing
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Rolled over: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Rolled over: Milestone reached
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Rolled over: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Rolled over: Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Rolled over: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Attended to and reached for objects: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Attended to and reached for objects: Milestone reached
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Attended to and reached for objects: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Attended to and reached for objects: Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Attended to and reached for objects: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Sat up without support: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Sat up without support: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Sat up without support: Milestone missed
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Sat up without support: Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Sat up without support: Missing
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Turned to locate a voice: Not applicable yet
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Development Milestones
24 months follow-up: Turned to locate a voice: Milestone reached
|
1 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Retrospective Cohort: Expectant Mothers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Prospective Cohort: Expectant Mothers
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Retrospective Cohort: Infants
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Prospective Cohort: Infants
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 participants at risk
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.
|
Prospective Cohort: Expectant Mothers
n=2 participants at risk
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.
|
Retrospective Cohort: Infants
n=5 participants at risk
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.
|
Prospective Cohort: Infants
n=2 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Congenital, familial and genetic disorders
Cleft lip
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
Other adverse events
| Measure |
Retrospective Cohort: Expectant Mothers
n=7 participants at risk
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.
|
Prospective Cohort: Expectant Mothers
n=2 participants at risk
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.
|
Retrospective Cohort: Infants
n=5 participants at risk
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.
|
Prospective Cohort: Infants
n=2 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
100.0%
2/2 • Number of events 2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Genital herpes simplex
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Laryngitis
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Investigations
Hepatic enzyme increased
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Investigations
Weight decreased
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
50.0%
1/2 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/5 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/7 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to end of study (up to 48.4 months)
|
0.00%
0/2 • From start of study drug administration up to end of study (up to 48.4 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER