Table 2. Outcomes in overall study population, stratified to sex and baseline score.
IQR = Interquartile range; 95% CI = 95% confidence interval; sc. = score; NNT = number needed to treat; n/a = Non-applicable
| Characteristic | Overall N=778 (females = 314) (males = 464) (sc. 3/4 = 26) (sc. 5 = 253) (sc. 6 = 499) | Proxalutamide N=423 (females = 163) (males = 260) (sc. 3/4 = 12) (sc. 5 = 137) (sc. 6 = 274) | Placebo N=355 (females = 151) (males = 204) (sc. 3/4 = 14) (sc. 5 = 116) (sc. 6 = 225) | Risk ratio (95% CI) NNT | p-value |
| Day 14 Scores – median (IQR) | 2 (1-7) | 1 (1-2) | 6 (2-8) | p < 0.0001 |
| Recovery rate over 14 days, no. (%) | 473 (60.8%) | 343 (81.1%) | 130 (36.6%) | 2.21 (1.92 – 2.56) NNT = 2.2 | p < 0.0001 |
| Females | 185 (58.9%) | 132 (81.0%) | 53 (35.1%) | 2.31 (1.83 – 2.91) p<0.0001 | NNT=2.2 |
| Males | 288 (62.1%) | 211 (81.2%) | 77 (37.7%) | 2.15 (1.79 – 2.59) p<0.0001 | NNT=2.3 |
| Baseline Scores 3 and 4 | 22 (84.6%) | 10 (83.3%) | 12 (85.7%) | 0.97 (0.70 – 1.35) p=0.87 | NNT=n/a |
| Baseline Score 5 | 183 (72.3%) | 123 (89.8%) | 60 (51.7%) | 1.73 (1.44 – 2.09) p<0.0001 | NNT=2.6 |
| Baseline Score 6 | 268 (53.7%) | 210 (76.6%) | 58 (25.8%) | 2.97 (2.36 – 3.75) p<0.0001 | NNT=2.0 |
| Recovery rate over 28 days no. (%) | 533 (68.5%) | 364 (86.1%) | 169 (47.6%) | 1.81 (1.61 – 2.03) NNT = 2.6 | p < 0.0001 |
| Females | 215 (68.5%) | 142 (87.1%) | 73 (48.3%) | 1.80 (1.51 – 2.15) p<0.0001 | NNT=2.6 |
| Males | 318 (68.5%) | 222 (85.4%) | 96 (47.1%) | 1.81 (1.56 – 2.12) p<0.0001 | NNT=2.6 |
| Baseline Scores 3 and 4 | 23 (88.5%) | 11 (91.7%) | 12 (85.7%) | 1.07 (0.81 – 1.41) p=0.63 | NNT=16.8 |
| Baseline Score 5 | 203 (80.2%) | 128 (93.4%) | 75 (64.7%) | 1.45 (1.25 – 1.67) p<0.0001 | NNT=3.5 |
| Baseline Score 6 | 307 (61.5%) | 225 (82.1%) | 82 (36.4%) | 2.25 (1.88 – 2.70) p<0.0001 | NNT=2.2 |
| All-cause mortality rate over 14 days, no. (%) | 172 (22.1%) | 34 (8.0%) | 138 (38.9%) | 0.21 (0.15 – 0.30) NNT = 3.2 | p < 0.0001 |
| Females | 66 (21.0%) | 11 (6.7%) | 55 (36.4%) | 0.18 (0.10 – 0.34) p<0.0001 | NNT=3.4 |
| Males | 106 (22.8%) | 23 (8.8%) | 83 (40.7%) | 0.21 (0.14 – 0.33) p<0.0001 | NNT=3.1 |
| Baseline Scores 3 and 4 | 1 (3.8%) | 0 (0.0%) | 1 (7.1%) | 0.38 (0.02 – 8.65) p=1.00 | NNT = 16.3 |
| Baseline Score 5 | 38 (15.0%) | 5 (3.6%) | 33 (28.4%) | 0.13 (0.05 – 0.32) p<0.0001 | NNT=4.0 |
| Baseline Score 6 | 133 (26.7%) | 29 (10.6%) | 104 (46.2%) | 0.23 (0.16 – 0.33) p<0.0001 | NNT=2.8 |
| All-cause mortality rate over 28 days, no. (%) | 216 (27.8%) | 45 (10.6%) | 171 (48.2%) | 0.22 (0.16 – 0.30) NNT = 2.7 | p < 0.0001 |
| Females | 87 (27.7%) | 14 (8.6%) | 73 (48.3%) | 0.18 (0.10 – 0.30) p<0.0001 | NNT=2.5 |
| Males | 129 (27.8%) | 31 (11.9%) | 98 (48.0%) | 0.25 (0.17 – 0.36) p<0.0001 | NNT=2.7 |
| Baseline Scores 3 and 4 | 2 (7.7%) | 0 (0.0%) | 2 (14.3%) | 0.23 (0.01 – 4.38) p=0.48 | NNT=7.8 |
| Baseline Score 5 | 45 (17.8%) | 6 (4.4%) | 39 (33.6%) | 0.13 (0.06 – 0.30) p<0.0001 | NNT=3.4 |
| Baseline Score 6 | 169 (33.9%) | 34 (14.2%) | 130 (57.8%) | 0.21 (0.15 – 0.30) p<0.0001 | NNT=2.2 |
| Median hospitalization days (IQR) | 10 (6-16) | 8 (6-13) | 12 (8-18) | p < 0.0001 |
| Post-randomization time-to-discharge alive, median days (IQR) | 7 (4-12) | 5 (3-8) | 9 (6-14) | p < 0.0001 |