Table 3.
Healthcare data reported by the site vs self-reported by participants and the number of overlapping reports between the two methods (FAS)
| Site report | Participant self-report | Overlapping reports | |
|---|---|---|---|
| Full analysis set, N | 4470 | 4470 | |
| Number of participants hospitalised, n (%) | 2529 (56.6) | 2177 (48.7) | 1771 (39.6) |
| Number of participants with any medical encounter, n (%) | 3759 (84.1) | 3480 (77.9) | 3323 (74.3) |
| Type of medical encounter, per participanta,b | 3759 | 3480 | 3323 |
| General practitioner/family physician | 2388 (63.5%) | 2661 (76.5%) | 2109 |
| Hospital outpatient department | 2189 (58.2%) | 1774 (51.0%) | 1371 |
| Para-medical services | 760 (20.2%) | 840 (24.1%) | 345 |
| Emergency department | 593 (15.8%) | 618 (17.8%) | 402 |
| Hospital inpatient department | 377 (10.0%) | 417 (12.0%) | 270 |
| Home care | 22 (0.6%) | 11 (0.3%) | 3 |
| Intensive care unit | 5 (0.1%) | 5 (0.1%) | 0 |
| Number of participants with any procedure/intervention,c n (%) | 1966 (44.0%) | 1976 (44.2%) | 1493 (33.4%) |
| Diagnostic | 1598 (81.3%) | 1661 (84.1%) | 1136 |
| Interventional | 661 (33.6%) | 670 (33.9%) | 419 |
| Site report | Participant self-report | Overlapping reports | |
| Patients with an IED event, n (%) | 4 (0.1) | 4 (0.1) | - |
| Number of patients hospitalised, n (%) | 4 (0.1) | 4 (0.1) | - |
| Number of patients with any medical encounter, n (%) | 4 (100.0) | 4 (100.0) | - |
| Type of medical encounter, per patienta,b | 4 | 4 | - |
| Hospital inpatient department | 4 (100.0%) | 3 (75.0%) | - |
| Hospital outpatient department | 4 (100.0%) | 2 (50.0%) | - |
| General practitioner/family physician | 2 (50.0%) | 4 (100.0%) | - |
| Emergency department | 1 (25.0%) | 0 | - |
| Para-medical services | 0 (0) | 1 (25.0%) | - |
| Number of patients with any procedure/intervention, n (%) | 4 (100.0) | 4 (100.0) | - |
| Diagnostic | 4 | 4 | - |
| Interventional | 0 | 3 | - |
aParticipants are counted only once for any given category but may appear in multiple categories
bPercentages in the specified group are calculated using the total number of participants with non-missing data in the denominator
cNumber of participants excluding those with an IED event, n = 4,466
FAS full analysis set, IED invasive Escherichia coli disease