Table 3.
Test Group | Within Group Analysis of Test Group | Placebo Group | P➔T ** Crossover Group | Within Group Analysis | Between Group Analysis | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo Group | P➔T ** Crossover Group | |||||||||||||||||
Day 0 | Day 30 | Day 60 | Day 0–30 | Day 30–60 | Day 0–60 | Day 0 | Day 30 | Day 60 | Day 0–30 | Day 30–60 | Day 0 | Day 30 | ||||||
Mean ± SE | Mean ± SE | Mean ± SE | % Change | p Value # | % Change | p Value # | % Change | p Value # | Mean ± SE | Mean ± SE | Mean ± SE | % Change | p Value # | % Change | p Value # | p Value $ | p Value $ | |
CD45 | 2148.03 ± 159.54 | 2492.41 ± 105.24 | 2854.3 ± 92.85 | 12.07 | 0.032 | 14.52 | <0.001 | 32.88 | 0.001 | 2201.22 ± 191.39 | 1852.96 ± 122.25 | 2255.87 ± 132.64 | −15.44 | 0.009 | 21.74 | 0.036 | 0.833 | 0.001 |
CD3 | 1334.71 ± 98.24 | 1699.4 ± 76.06 | 1874.02 ± 90.06 | 19.46 | 0.001 | 10.28 | 0.026 | 40.41 | 0.002 | 1595.16 ± 109.60 | 1253.94 ± 68.87 | 1550.93 ± 96.93 | −22.00 | 0.002 | 23.68 | 0.01 | 0.091 | <0.001 |
CD4 | 738.23 ± 54.71 | 918.25 ± 49.85 | 1042.82 ± 49.84 | 17.26 | 0.003 | 13.57 | 0.018 | 41.26 | 0.001 | 876.88 ± 59.59 | 669.3 ± 47.57 | 860.34 ± 54.87 | −24.13 | 0.001 | 28.54 | 0.005 | 0.101 | 0.002 |
CD8 | 498.95 ± 39.11 | 603.31 ± 24.77 | 716.47 ± 52.85 | 14.57 | 0.005 | 18.76 | 0.028 | 43.6 | 0.003 | 604.37 ± 53.12 | 455.06 ± 24.24 | 594.18 ± 43.47 | −25.13 | 0.02 | 30.57 | 0.01 | 0.124 | <0.001 |
CD19 | 661.53 ± 29.81 | 761.98 ± 30.87 | 974.39 ± 63.75 | 10.31 | 0.034 | 27.88 | 0.021 | 47.29 | 0.004 | 751.06 ± 32.04 | 734.83 ± 28.08 | 870.1 ± 42.12 | −1.87 | 0.733 | 18.41 | 0.006 | 0.053 | 0.522 |
NK | 361.92 ± 66.06 | 467.36 ± 68.41 | 552.68 ± 62.51 | 19.08 | 0.046 | 18.26 | 0.015 | 52.71 | <0.001 | 341.95 ± 60.83 | 341.26 ± 42.73 | 465.47 ± 35.37 | −0.15 | 0.989 | 36.4 | 0.027 | 0.826 | 0.132 |
IFNγ | 72.15 ± 7.25 | 100.60 ± 10.67 | 111.61 ± 7.64 | 39.44 | <0.001 | 10.94 | 0.056 | 54.69 | <0.001 | 73.36 ± 6.11 | 72.06 ± 5.70 | 97.65 ± 9.01 | −1.77 | 0.749 | 35.51 | <0.001 | 0.899 | 0.028 |
IL4 | 3.92 ± 1.42 | 7.16 ± 1.51 | 9.30 ± 1.13 | 82.53 | 0.047 | 29.89 | 0.053 | 137.06 | 0.004 | 4.20 ± 1.94 | 3.21 ± 1.35 | 6.29 ± 0.80 | −23.50 | 0.814 * | 95.87 | 0.038 * | 0.817 | 0.03 |
# Within group significance using the t-test (equal variances). $ Between the group significance using the t-test for independent groups. * p value using Mann–Whitney test. P➔T ** Placebo group crossed over to the test group in the extension study period.