Table 4. AUROC, cut-points, summary statistic and Proportion Treatment Effect Explained (PTE) for measures of change in Glasgow Coma Scale assessed at various times after start of treatment in the AQUAMAT study.
AS, Artesunate; QN, Quinine; Se, Sensitivity; Sp, Specificity.
| Surrogate measurement | Hour 6 | Hour 12 | Hour 18 | Hour 24 |
|---|---|---|---|---|
| AUROC (95% CI) | ||||
| N | 545 | 524 | 508 | 487 |
| Absolute change | 0.76 (0.70–0.83) | 0.82 (0.74–0.89) | 0.82 (0.76–0.88) | 0.87 (0.80–0.93) |
| Relative Change | 0.75 (0.69–0.82) | 0.80 (0.71–0.88) | 0.78 (0.69–0.87) | 0.84 (0.76–0.93) |
| Log slope | 0.75 (0.69–0.82) | 0.83 (0.76–0.89) | 0.85 (0.78–0.91) | 0.87 (0.82–0.93) |
| Cut-point (Se,Sp) | ||||
| Absolute change | 1 (0.60, 0.81) | 1 (0.80, 0.73) | 2 (0.78, 0.77) | 2 (0.84, 0.81) |
| Relative Change | 10 (0.60, 0.81) | 10 (0.80, 0.73) | 25 (0.77, 0.71) | 38 (0.79, 0.81) |
| Log slope | .02 (0.60, 0.81) | .01 (0.79, 0.78) | .01 (0.79, 0.80) | .01 (0.87, 0.78) |
| Mean value of surrogate, adjusted for baseline | ||||
| Absolute change (Mean, 95% CI) | ||||
| Mortality | ||||
| Alive | 2* (2,2) | 4* (3, 4) | 5* (4, 5) | 5* (5, 6) |
| Death | -1 (-1, 0) | 0 (-1, 1) | 0 (-1, 1) | 0 (-1, 1) |
| Treatment | ||||
| AS | 2 (1,2) | 3 (2, 3) | 4 (3, 4) | 4 (4, 5) |
| QN | 2 (2,2) | 3 (3, 4) | 4 (4, 5) | 5 (4, 5) |
| Relative Change (Mean, 95% CI) | ||||
| Mortality | ||||
| Alive | 32* (28, 35) | 54* (49, 59) | 70* (65, 75) | 80* (75, 85) |
| Death | -9 (-20, 2) | -11 (-27, 5) | -6 (-25, 14) | -15 (-36, 5) |
| Treatment | ||||
| AS | 25 (20, 30) | 41 (34, 48) | 55 (48, 63) | 63 (55, 71) |
| QN | 30 (24, 35) | 49 (43, 56) | 62 (55, 69) | 70 (62, 77) |
| Log slope (Mean, 95% CI) | ||||
| Mortality | ||||
| Alive | 0.04* (0.03, 0.04) | 0.04* (0.03, 0.04) | 0.03* (0.03, 0.04) | 0.03* (0.03, 0.04) |
| Death | -0.02 (-0.03, -0.01) | -0.02 (-0.03, -0.02) | -0.02 (-0.03, -0.01) | -0.02 (-0.03, -0.01) |
| Treatment | ||||
| AS | 0.03 (0.02, 0.04) | 0.03 (0.02,0.03) | 0.03 (0.02, 0.03) | 0.03 (0.02, 0.03) |
| QN | 0.04 (0.03, 0.04) | 0.03 (0.03, 0.04) | 0.03 (0.03, 0.03) | 0.03 (0.02, 0.03) |
| PTE (95% CI) | ||||
| Absolute change | -1.22 (-5.58, 9.34) | -3.53 (-7.52, 8.04) | -2.72 (-7.71, 6.90) | -3.65 (-11.52, 11.76) |
| Relative Change | -0.93 (-7.41, 8.08) | -2.93 (-5.43, 5.89) | -2.14 (-4.95, 4.40) | -3.20 (-9.67, 9.02) |
| Log slope | -1.24 (-6.89, 8.81) | -1.67 (-10.74, 9.42) | -1.54 (-16.64, 10.21) | -1.83 (-15.13, 14.56) |
* P-value < 0.05.