Table 4.
Quantitative coronary angiography results
| Modified intent-to-treat population, coronary artery score (mm) | Placebo (n = 116) | CER-001, 3 mg/kg (n = 115) | CER-001, 6 mg/kg (n = 119) | CER-001, 12 mg/kg (n = 111) |
|---|---|---|---|---|
| Baseline (means ± SD) | 1.961 ± 0.385 | 2.034 ± 0.392 | 2.003 ± 0.438 | 1.985 ± 0.499 |
| Follow-up (means ± SD) | 1.940 ± 0.384 | 1.997 ± 0.382 | 1.981 ± 0.436 | 1.970 ± 0.502 |
| Nominal change (adjusted mean) (95% CI) | −0.022 (−0.039, −0.006) | −0.036 (−0.052, −0.020) | −0.022 (−0.038, −0.006) | −0.015 (−0.032, 0.001) |
| P-value vs. placebo | N/A | 0.25 | 0.99 | 0.55 |
| Cumulative coronary stenosis score (%) | ||||
| Baseline (means ± SD) | 167.66 ± 100.73 | 169.27 ± 105.90 | 181.23 ± 109.01 | 165.81 ± 111.18 |
| Follow-up (means ± SD) | 167.13 ± 101.04 | 171.90 ± 108.72 | 182.00 ± 109.41 | 165.01 ± 111.20 |
| Nominal change (adjusted mean) (95% CI) | −0.51 (−2.42, 1.41) | 2.65 (1.00, 4.29) | 0.71 (−1.40, 2.82) | −0.77 (−2.66, 1.13) |
| P-value vs. placebo | N/A | 0.01 | 0.40 | 0.85 |
Given that the P-value for the primary endpoint was not significant, all P-values in this table represent nominal values.