Table 3.
SPI and TOpA: MATRIX-1 and MATRIX-2 populations combined (mITT population)
| Parameter | MATRIX-1 and MATRIX-2 combined | |
|---|---|---|
| INL-001 (n = 404) | Placebo collagen-matrix (n = 206) | |
| SPI24 | ||
| Mean (SEM) | 87.1 (2.34) | 111.6 (3.22) |
| Median | 82.5 | 112.3 |
| Observed P valuea vs. placebo collagen-matrix | < 0.0001 | |
| TOpA24 (mg IV morphine eq) | ||
| Median | 5.0 | 12.3 |
| Observed P valueb vs. placebo collagen-matrix | < 0.0001 | |
| SPI48 | ||
| Mean (SEM) | 186.1 (4.65) | 209.2 (6.44) |
| Median | 180.5 | 208.8 |
| Observed P valuea vs. placebo collagen-matrix | 0.0033 | |
| TOpA48 (mg IV morphine eq) | ||
| Median | 7.0 | 15.0 |
| Observed P valueb vs. placebo collagen-matrix | < 0.0001 | |
| SPI72 | ||
| Mean (SEM) | 268.0 (6.91) | 291.3 (9.55) |
| Median | 253.0 | 274.9 |
| Observed P valuea vs. placebo collagen-matrix | 0.0441 | |
| TOpA72 (mg IV morphine eq) | ||
| Median | 9.0 | 17.0 |
| Observed P valueb vs. placebo collagen-matrix | 0.0004 | |
ANOVA analysis of variance, IV intravenous, eq equivalents, mITT modified intent-to-treat, NT not tested, SEM standard error of the mean, SPI24, SPI48, SPI72 sum of pain intensity from time 0 through 24, 48, and 72 h, TOpA24, TOpA48, TOpA72 total use of opioid analgesia from time 0 through 24, 48, and 72 h
aP value represents the difference least-squares means between treatment groups from the ANOVA model with treatment, study, sex, and history of previous ipsilateral hernia repair as main effects
bP value from Wilcoxon rank sum test