Table 1.
Overview of the OPUS, OrPHeUS and EXPOSURE 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 |
aData cut-off for this analysis was 30 Nov 2019
Percentages might not add up to 100.0% due to rounding
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