Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to treatment with BUSCAPINA COMPOSITUM N from March to December 2016 in patients from Metropolitan Lima (PASS PERU)

Study identification

• EU PAS number:
  EUPAS15008
• Study ID:
  15009
• Official title and acronym:
  Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to treatment with BUSCAPINA COMPOSITUM N from March to December 2016 in patients from Metropolitan Lima (PASS PERU)
• DARWIN EU® study:
  No
• Study countries:
  Peru
• Study description:
  What AE occur in routine clinical practice, what is the incidence of AE and ADR, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.
• Study status:
  Planned

Research institutions and networks

Institutions

Magaly Blas

Boticas InkaFarma Lima, Mifarma Lima, Arcángel Lima, Boticas y Salud Lima, Nortfarma Lima, Seguro Social de Salud Lima, Clínica Internacional Lima, Clínica Médica Cayetano Heredia Lima, América Salud Lima, Corporación Boticas Perú Lima

Study timelines

Date when funding contract was signed

Planned:21/12/2015

Study start date

Planned:05/09/2016

Data analysis start date

Planned:12/09/2016

Date of final study report

Planned:05/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable