A non-interventional observational retrospective study for the study of the risk factors associated to the related to treatment adverse events occurred by the administration of allergen specific immunotherapy administered by sublingual route (ALK-SLI-2013-01)

Study identification

• EU PAS number:
  EUPAS6012
• Study ID:
  28562
• Official title and acronym:
  A non-interventional observational retrospective study for the study of the risk factors associated to the related to treatment adverse events occurred by the administration of allergen specific immunotherapy administered by sublingual route (ALK-SLI-2013-01)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  A non-interventional, observational, retrospective, multi-centre, open-label study. The study will include 20 investigators with 10 patients each into the study. Overall, there are 200 patients to be included.
• Study status:
  Finalised

Research institutions and networks

Institutions

NA

Study timelines

Date when funding contract was signed

Planned:30/04/2014

Actual:01/01/2014

Study start date

Planned:01/05/2014

Actual:18/03/2014

Data analysis start date

Planned:01/09/2014

Actual:18/02/2015

Date of final study report

Actual:18/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ALK- Abello

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable