Table 2.
Intention‐to‐treat | Baseline | Follow‐up | Within‐Group change | Between‐Group difference | ||
---|---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Change (95% CI) | P | Difference (95% CI) | P | |
NK cells tumour, cells/mm2 | ||||||
EX | 1.51 (1.86) | 1.86 (1.50) | 0.35 (−0.67 to 1.36) | 0.489 | −0.09 (−1.85 to 1.66) | 0.913 |
CON | 1.05 (1.37) | 1.49 (1.17) | 0.44 (−0.99 to 1.88) | 0.534 | ||
NK cells healthy, cells/mm2 * | ||||||
EX | 2.37 (3.33) | 2.24 (2.12) | −0.13 (−1.87 to 1.62) | 0.884 | 1.75 (−1.34 to 4.84) | 0.255 |
CON | 4.15 (4.50) | 2.26 (1.59) | −1.88 (−4.43 to 0.67) | 0.142 |
Per‐protocol | Mean (SD) | Mean (SD) | Change (95% CI) | P | Difference (95% CI) | P |
---|---|---|---|---|---|---|
NK cells tumour, cells/mm2 | ||||||
EX | 0.47 (0.48) | 2.07 (1.65) | 1.60 (0.59 to 2.62) | 0.004 | 1.16 (−0.31 to 2.63) | 0.114 |
CON | 1.05 (1.37) | 1.49 (1.17) | 0.44 (−0.62 to 1.50) | 0.396 | ||
NK cells healthy, cells/mm2 * | ||||||
EX | 0.62 (0.78) | 1.95 (1.48) | 1.33 (−0.82 to 3.48) | 0.210 | 3.23 (0.07 to 6.38) | 0.046 |
CON | 4.15 (4.50) | 2.26 (1.59) | −1.90 (−4.21 to 0.42) | 0.102 |
Means (SDs) are based on all available data for EX and CON at baseline and follow‐up with intention‐to‐treat (EX, n = 20 and CON, n = 10) and per‐protocol (EX, n = 11, and CON, n = 10) analysis. The mean differences are estimated means from the mixed models and therefore, within‐group change may not reflect the numerical difference between baseline and follow‐up.
Bold values statistically significant at P < 0.05.
The analyses in healthy tissue are based on CON, n = 9 at baseline due to lack of normal tissue in core needle biopsy.