NN8640-4515 A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate long-term safety of Sogroya® (somapacitan) in adults with growth hormone deficiency (AGHD) under routine clinical practice

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SOMAPACITAN
• Medical condition to be studied:
  Growth hormone deficiency
• Additional medical condition(s):
  Adults with growth hormone deficiency

Population studied

• Age groups:
  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:
  400

Study design details

• Main study objective:
  To investigate long-term safety of Sogroya® (somapacitan) therapy in patients with AGHD in the setting of routine clinical practice with special focus on neoplasms and diabetes mellitus type 2.
• Outcomes:
  Number of Adverse drug reaction (ADRs) Incident Neoplasm Incident Diabetes Mellitus type 2, Number of Adverse Events (AEs) Number of Serious Adverse Events (SAEs) Number of Medication Errors (incorrect dose administration rate)
• Data analysis plan:
  Frequencies of ADRs during the study period will be summarised by MedDRA SOC and PT. This summary is displayed with number and proportion of patients with at least one event, number of event and event rate (events per 100 patient-years of exposure). In addition, incidence rates will be calculated for the endpoints Neoplasm and Diabetes Mellitus type 2.

Documents

Study report

4515 regulatory pass progress report no. 1 eu-pas-reg redacted

4515 regulatory pass progress report no. 2 eu-pas-reg redacted

Study, other information

4515 regulatory pass progress report no. 2 eu-pas-reg redacted.pdf