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Table 1 Overview of the OPUS, OrPHeUS and EXPOSURE databases

From: Standardizing registry data to the OMOP Common Data Model: experience from three pulmonary hypertension databases

 

OPUS

OrPHeUS

EXPOSURE

Study identifier

NCT02126943

NCT03197688

EUPAS19085

Study type

Multi-centre, prospective drug registry of PH patients newly treated with macitentan

Multi-centre, retrospective medical chart review of PH patients newly treated with macitentan

Multi-centre, prospective cohort study of patients with PAH newly treated with either selexipag or any other PAH-specific therapy

Region

USA

USA

Europe and Canada

Date ranges

Apr 2014 – Apr 2020

Oct 2013 to Mar 2017

Sept 2017 – ongoinga

Patients in database, N

2722

3142

758

Age at enrolment in database, mean (SD), years [N]

60.93 (14.15)

[N = 2682]

60.21 (15.06)

[N = 3060]

59.96 (15.07)

[N = 752]

Gender, %

 Female

71.6

72.2

68.6

 Male

26.9

25.2

31.3

 Missing

1.4

2.5

0.1

Source data format

 Conditions

MedDRA and free text

MedDRA and free text

MedDRA and free text

 Drugs

WHODrug and free text

WHODrug and free text

WHODrug and free text

  1. aData cut-off for this analysis was 30 Nov 2019
  2. Percentages might not add up to 100.0% due to rounding
  3. MedDRA Medical Dictionary for Regulatory Activities; OPUS OPsumit® USers OrPHeUS OPsumit® Historical USers; PH pulmonary hypertension; PAH pulmonary arterial hypertension; SD standard deviation; USA United States of America; WHODrug World Health Organization Drug Dictionary