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

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

Time frame: From start of study drug administration up to end of study (up to 48.4 months)

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

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

Time frame: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)

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.

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

Time frame: 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.

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

Time frame: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)

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.

Time frame: 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.

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

Time frame: At 6, 12, 18 and 24 months follow-up

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.

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

Time frame: At 6, 12, 18 and 24 months follow-up

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.

Time frame: 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.

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

Time frame: From start of study drug administration up to end of study (up to 48.4 months)

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

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

Time frame: At or after delivery/end of pregnancy (up to 40 weeks)

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.