Table 2 Summary of primary and secondary outcome measures
From: Autologous macrophage therapy for liver cirrhosis: a phase 2 open-label randomized controlled trial
Single or triple infusion | Control | Difference in change | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (n = 27) | 90 d (n = 26) | Baseline to 90-d change (n = 26) | Baseline (n = 24) | 90 d (n = 24) | Baseline to 90-d change (n = 24) | |||||||||||
Mean | s.d. | Mean | s.d. | Mean | s.d. | Mean | s.d. | Mean | s.d. | Mean | s.d. | Mean | 95% CI | P | Test | |
MELD | 11.89 | 1.77 | 11.43 | 2.00 | −0.48 | 1.10 | 12.00 | 1.79 | 12.40 | 3.15 | 0.39 | 1.94 | −0.87 | (−1.79, 0.04) | 0.0601 | Unequal |
UKELD | 50.97 | 2.05 | 50.61 | 2.34 | −0.39 | 2.49 | 50.93 | 1.90 | 50.84 | 2.13 | −0.09 | 1.97 | −0.30 | (−1.58, 0.98) | 0.639 | Equal |
Albumin | 34.19 | 3.97 | 33.96 | 3.67 | −0.38 | 2.42 | 31.54 | 5.17 | 34.61 | 3.13 | −0.17 | 2.33 | 0.62 | (−0.71, 1.95) | 0.33 | Equal |
ALT | 33.59 | 16.13 | 33.00 | 17.63 | −1.12 | 9.51 | 37.67 | 27.34 | 34.17 | 26.3 | −3.5 | 7.58 | 2.38 | (−2.53, 7.30) | 0.33 | Equal |
Bilirubin | 33.85 | 13.79 | 31.88 | 14.99 | −2.15 | 8.69 | 36.08 | 14.47 | 35.13 | 16.08 | −0.96 | 7.90 | −1.20 | (−5.93, 3.54) | 0.6141 | Equal |
INR | 1.30 | 0.15 | 1.26 | 0.15 | −0.03 | 0.07 | 1.22 | 0.17 | 1.24 | 0.20 | 0.02 | 0.08 | 0.0861 | Fisherʼs exact | ||
Creatinine | 72.59 | 18.59 | 72.58 | 20.59 | 0.19 | 6.94 | 83.88 | 25.10 | 92.46 | 47.38 | 8.58 | 34.12 | 8.39 | (5.86, 10.92) | 0.2255 | Equal |
ELF | 11.55 | 1.07 | 11.72 | 0.90 | 0.27 | 0.88 | 12.33 | 0.99 | 12.24 | 1.43 | −0.09 | 1.22 | 0.36 | (−0.24, 0.96) | 0.2328 | Equal |
VCTE | 34.12 | 15.43 | 38.51 (n = 19) | 18.84 | 5.97 (n = 19) | 17.82 | 40.62 (n = 18) | 18.29 | 31.46 | 15.18 | −7.73 | 9.69 | 13.69 | (3.97, 23.42) | 0.0074 | Unequal |
C3M | 15.60 | 4.89 | 15.37 (n = 25) | 5.32 | −0.53 (n = 25) | 3.26 | 17.10 (n = 23) | 7.92 | 17.11 | 7.66 | 0.15 (n = 23) | 4.37 | −0.68 | (−2.90, 1.55) | 0.5444 | Equal |
Pro-C3 | 29.53 | 14.83 | 24.78 (n = 25) | 10.92 | −3.82 (n = 25) | 8.40 | 36.35 (n = 23) | 20.47 | 33.23 | 21.67 | −3.99 (n = 23) | 7.51 | 0.17 | (−4.48, 4.81) | 0.9426 | Equal |