Follow-up of adult patients treated with growth hormone NUTROPIN Aq® (Nutropin in Adults)

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:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational Model :Case-only

Study drug and medical condition

• Name of medicine:
  NUTROPINAQ
• Study drug International non-proprietary name (INN) or common name:
  SOMATROPIN
• Anatomical Therapeutic Chemical (ATC) code:
  (H01AC01) somatropin

  somatropin
• Additional medical condition(s):
  Somatotrope deficit

Population studied

• Short description of the study population:
  Adult patients treated with growth hormone NUTROPIN Aq®.
• 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:
  205

Study design details

• Main study objective:
  The objectives of this observational study are: - Define the profile of patients treated with NutropinAq® and describe the conditions for initiation and follow-up of treatment - Assess the safety of NutropinAq® in adults - Collect data on the quality of life of adults treated with NutropinAq®.
• Outcomes:
  Profile of patients treated with NutropinAq® and conditions for initiation and follow-up of treatment, Safety of NutropinAq® in adults. Quality of life of adults treated with NutropinAq®.
• Data analysis plan:
  Descriptive analysis of all collected data at the baseline and follow-up visits according a statistical plan validated by authorities