NN7999-4413: Adverse Event Data Collection from External Registries on Nonacog Beta Pegol

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REFIXIA
• Medical condition to be studied:
  Haemophilia B with anti factor IX

  Haemophilia B without inhibitors

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol.
• Outcomes:
  Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B, Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B
• Data analysis plan:
  This is a purely descriptive study and the statistical analyses and presentations do not include any testing of pre-specified hypothesesNovo Nordisk will be responsible for all statistical analyses.