Table 2 Protocol deviations by year and site
Number of protocol deviations, (%a) (N = 4074) | Cumulative number of enrollments (N = 5407) | Ratio of protocol deviations to cumulative enrollments (95% CI) | |
|---|---|---|---|
Year | |||
2016 | 16 (0.39%) | 54 | 0.30 (0.18–0.48) |
2017 | 1221 (29.97%) | 2335 | 0.52 (0.49–0.55) |
2018 | 723 (17.75%) | 4614 | 0.16 (0.15–0.17) |
2019 | 237 (5.82%) | 5407 | 0.04 (0.039–0.05) |
2020 | 1815 (44.55%) | 5407 | 0.34 (0.32–0.35) |
2021 | 62 (1.52%) | 5407 | 0.01 (0.009–0.014) |
Site | |||
A | 237 (5.82%) | 505 | 0.47 (0.41–0.53) |
B | 116 (2.85%) | 429 | 0.27 (0.23–0.32) |
C | 100 (2.45%) | 492 | 0.20 (0.17–0.25) |
D | 313 (7.68%) | 511 | 0.61 (0.55–0.69) |
E | 363 (8.91%) | 354 | 1.03 (0.93–1.14) |
F | 478 (11.73%) | 353 | 1.35 (1.24–1.48) |
G | 367 (9.01%) | 407 | 0.90 (0.81–1.0) |
H | 425 (10.43%) | 333 | 1.28 (1.16–1.40) |
I | 86 (2.11%) | 64 | 1.34 (1.09–1.66) |
J | 661 (16.22%) | 358 | 1.85 (1.71–1.99) |
K | 87 (2.13%) | 483 | 0.18 (0.15–0.22) |
L | 117 (2.87%) | 486 | 0.24 (0.20–0.29) |
M | 189 (4.64%) | 342 | 0.55 (0.48–0.64) |
N | 535 (13.13%) | 290 | 1.85 (1.70–2.0) |
All sites | 4074 (median 275, IQR 116–425) | 5407 (median 382.5, IQR 342–486) | 1.33 (median 0.76, IQR (0.27–1.34) |