Table 5.
Data concerning the trial period of countries participating in the FAITH trial
| NL (N = 14) |
CA (N = 11) |
US (N = 29) |
P-value | |
|---|---|---|---|---|
| Time between ethics approval and start trial (days) | 41 (10 - 139) | 232 (98 - 423) | 87 (45 - 255) | 0.027a |
| Enrolment period (days) | 423 (381 - 509) | 482 (267 - 663) | 283 (142 - 360) | 0.001b |
| Inclusions | 13 (7 - 27) | 3 (0 - 5) | 3 (1 - 6) | < 0.001c |
| Registered patients | 23 (12 - 36) | 54 (3 - 75) | 16 (5 - 27) | 0.060 |
| Patients missed for registration1 | 35 (10 - 81) | Unknown | Unknown | |
| Inclusions (n per month) | 1.03 (0.43 - 2.21) | 0.14 (0.00 - 0.28) | 0.31 (0.09 - 0.62) | < 0.001d |
| Total patients (n per month) | 2.49 (1.60 - 3.64) | 2.76 (0.60 - 8.75) | 1.96 (1.11 - 3.75) | 0.574 |
| Proportion inclusions (% of total) | 34.4 (23.8 - 62.6) | 3.93 (0.00 - 13.2) | 16.7 (2.50 - 31.3) | 0.001e |
| Proportion patients that were missed for registration of total1 (%) | 57.4 (32.2 - 65.2) | Unknown | Unknown | |
| Completed follow-ups (%) | 82.6 (80.0 - 84.6) | 83.5 (72.7 - 95.2) | 70.0 (60.0 - 88.1) | 0.217 |
| Follow-ups in window (%) | 77.1 (71.0 - 82.2) | 85.9 (81.0 - 95.0) | 85.7 (70.0 - 100.0) | 0.073 |
NL, the Netherlands; CA, Canada; US, United States.
Numbers in the headers represent the number of sites per country that data were available for.
Data are presented as median with P25-P75 given between brackets.
Statistics were calculated using the Kruskal-Wallis ANOVA.
1 Data available for NL only.
Post-hoc pair wise comparisons were performed using a Mann-Whitney U-test: a Statistical significance was reached when comparing NL vs. CA (p = 0.010), other groups: not significant. b Statistical significance was reached when comparing NL vs. US (p < 0.001), other groups: not significant. c Statistical significance was reached when comparing NL vs. CA (p = 0.002) and NL vs. US (p < 0.001), CA vs. US: not significant. d Statistical significance was reached when comparing NL vs. CA (p = 0.001) and NL vs. US (p = 0.001), CA vs. US: not significant. e Statistical significance was reached when comparing NL vs. CA (p < 0.001) and NL vs. US (p = 0.009), CA vs. US: not significant.