Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database (205846)

Study identification

• EU PAS number:
  EUPAS13473
• Study ID:
  42117
• Official title and acronym:
  Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database (205846)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  A descriptive analysis of neuropsychiatric diagnoses made within a large, geographically-diverse, real-world clinical setting utilizing prospectively-collected electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) Observational Database
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 07/04/2016

Actual: 07/04/2016

Study start date

Planned: 18/05/2016

Actual: 18/05/2016

Data analysis start date

Planned: 18/05/2016

Actual: 18/05/2016

Date of final study report

Planned: 01/06/2017

Actual: 29/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Regulatory

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