TAK-771-4004: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective case series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  HUMAN NORMAL IMMUNOGLOBULIN
• Medical condition to be studied:
  Pregnancy

  Gestational hypertension

  Congenital anomaly

  Foetal malformation

  Abortion spontaneous

  Stillbirth

Population studied

• Short description of the study population:
  The study population comprised of pregnant women exposed to HyQvia during pregnancy identified through MarketScan research database from 2014 to 2020 in the US.; Inclusion criteria: ; • Pregnant human females ages 16-44; • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.; ; Exclusion criteria: ; • NA
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  7

Study design details

• Main study objective:
  Primary objectives of study are to describe the maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in HyQvia-exposed pregnancies that would be identified within a US healthcare claims database of commercially insured individuals.
• Outcomes:
  Number of Participants with Major Congenital Malformations in the Infant Number of Participants with Spontaneous Abortion Number of Participants with Stillbirth Number of Participants with Preterm Birth Number of Participants Being Small for Gestational Age Number of Participants With Admission to Neonatal Intensive Care Unit Number of Participants With Any Major Clinical Diagnosis/Procedure
• Data analysis plan:
  Description of complete claims profiles will be performed by reporting maternal and infant characteristics and outcomes after exposure to HyQvia during pregnancy. Separate narratives for each participant, will describe sociodemographic characteristics(age), medical history(comorbidities and concomitant medications), timing of HyQvia dispensations/administration, recorded indication, obstetric characteristics(e.g. infertility treatments, multiples), clinical diagnoses during pregnancy(e.g. infections), obstetric outcomes(e.g. preeclampsia), infant characteristics(sex), presence of pre-specify and other adverse pregnancy outcomes. Summary report will quantify frequency of pre-specified outcomes(e.g. out of xx pregnancies exposed, yy ended in livebirths). Given small numbers, no absolute risks(with 95% confidence intervals) will be calculated. Since there is no reference group, no measures of association(e.g. relative risks) will be estimated. No causal inference will be attempted.

Documents

Study results

TAK-771-4004‐clinical‐study‐report‐redact