Table 3.
Crude and PCR-adjusted ACPR by day: ITT analysis set
| 800:640 (N = 143) | 800:960 (N = 148) | 800:1440 (N = 146) | Total (N = 437) | ||
|---|---|---|---|---|---|
| Day 28 | |||||
| Crude ACPR | n/r (%) | 76/143 (53.1) | 79/148 (53.4) | 92/146 (63.0) | 247/437 (56.5) |
| 95% CIa | [44.63; 61.53] | [45.01; 61.61] | [54.64; 70.85] | [51.73; 61.23] | |
| PCR-adjusted ACPR | n/r (%) | 77/143 (53.8) | 82/148 (55.4) | 95/146 (65.1) | 254/437 (58.1) |
| 95% CIa | [45.32; 62.21] | [47.02; 63.57] | [56.75; 72.76] | [53.34; 62.79] | |
| Day 42 | |||||
| Crude ACPR | n/r (%) | 63/143 (44.1) | 66/148 (44.6) | 68/146 (46.6) | 197/437 (45.1) |
| 95% CIa | [35.77; 52.59] | [36.43; 52.98] | [38.29; 55.01] | [40.35; 49.88] | |
| PCR-adjusted ACPR | n/r (%)a | 67/143 (46.9) | 72/148 (48.6) | 73/146 (50.0) | 212/437 (48.5) |
| 95% CIa | [38.47; 55.37] | [40.36; 56.99] | [41.62; 58.38] | [43.74; 53.31] | |
| Day 63b | |||||
| Crude ACPR | n/r (%)a | 50/136 (36.8) | 49/140 (35.0) | 58/135 (43.0) | 157/411 (38.2) |
| 95% CIa | [28.67; 45.45] | [27.14; 43.51] | [34.48; 51.76] | [33.48; 43.09] | |
| PCR-adjusted ACPR | n/r (%)a | 50/136 (36.8) | 54/140 (38.6) | 59/135 (43.7) | 163/411 (39.7) |
| 95% CIa | [28.67; 45.45] | [30.47; 47.16] | [35.19; 52.50] | [34.90; 44.57] | |
n number of patients in each category achieving ACPR, r total number of patients in the relevant analysis set with a defined response of Cure or Failure, N total number of patients in relevant analysis set
aClopper–Pearson
bPatients followed up to day 63 consented separately from the patients followed up to day 42; hence, total patient population is lower for day 63