European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry (EuIGFD)

• Serious adverse events including any occurrence of neoplasia [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  

• All other non-serious adverse events considered to be drug-related by the paediatric endocrinologist [ Time Frame: follow up to post-treatment visits ] [ Designated as safety issue: Yes ]
  
• All targeted adverse events [ Time Frame: follow up to post treatment visits ] [ Designated as safety issue: Yes ]
  
• All clinically significant laboratory abnormalities [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  
• Dose of Increlex® at the start of the treatment, dose escalation, concomitant medication, height, weight, pubertal age, predicted Adult Height, height velocity, final adult height, pubertal stage [ Time Frame: periodically assessed during the study until the final adult height is achieved ] [ Designated as safety issue: No ]
  
• Biological assessment : IGF-1 levels, IGFBP-3 levels, baseline GH concentrations and binding proteins. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  
• Genetic test results if available [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  

Drug: Increlex®
Increlex® (mecasermin [rDNA origin] injection), 10 mg/ml solution for injection, 20-120mcg/kg BID or 0,02 to 0,12 mg/kg BID, as prescribed by physician

Surveillance registry, defined as a post-authorisation observational registry, called the Eu-IGFD {European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database} which is intended primarily to monitor the safety of Increlex® replacement therapy in children with growth failure and secondly to follow the efficacy of this treatment. Patients who have already started Increlex® therapy before entering this observational registry may be included in this registry and data will be collected retrospectively.