An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  NGENLA
• Study drug International non-proprietary name (INN) or common name:
  SOMATROGON
• Anatomical Therapeutic Chemical (ATC) code:
  (H01AC08) somatrogon

  somatrogon

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  Estimate the incidence rates of neoplasms, and diabetes mellitus type 2, the primary safety events of interest in paediatric patients treated with somatrogon, and paediatric patients treated with once daily somatropin, in the course of routine clinical care.
• Outcomes:
  diabetes and neoplasms, immunogenicity, medication errors, long-term efficacy
• Data analysis plan:
  Baseline demographic and clinical characteristics will be described. For all the safety events of interest and efficacy measurements of interest, descriptive statistics, counts and proportions, crude incidence rates (ie, number of events per person years) and age/sex standardized incidence rates with associated two-sided 95% confidence intervals will be calculated as appropriate. Rates will be expressed as events/1,000 person-years of follow-up.