Treatment and outcomes
| . | GMI-1070 . | Placebo . | P . |
|---|---|---|---|
| First medical evaluation to treatment (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 14.85 (4.36) | 15.35 (5.33) | |
| LS mean (SE)† | 14.54 (0.72) | 15.37 (0.82) | .445 |
| Median (CI)‡ | 14.7 (13.1, 16.6) | 15.2 (12.5, 17.3) | .457 |
| Reason for discontinuation of study drug, N (%) | |||
| N | 43 | 33 | .288§ |
| Resolution of VOC | 28 (65.1) | 19 (57.6) | |
| Received maximum (15 doses) | 6 (14) | 5 (15.2) | |
| No improvement on day 5 | 1 (2.3) | 2 (6.1) | |
| AE | 8 (18.6) | 4 (12.1) | |
| Other | 0 (0) | 3 (9.1) | |
| End point component first achieved, N (%) | |||
| N | 43 | 33 | |
| Sustained decrease in VAS score and transition to oral analgesia | 19 (44.2) | 15 (45.5) | |
| Agreement about readiness for discharge | 18 (41.9) | 16 (48.5) | |
| Hospital discharge | 8 (18.6) | 4 (12.1) | |
| Time to resolution of VOC (h) (composite end point)|| | |||
| N | 43 | 33 | |
| Mean (SD)* | 110.13 (128.04) | 147.72 (139.42) | |
| LS mean (SE)†|| | 103.64 (20.85) | 144.60 (23.54) | .192 |
| Median (CI)ঠ| 69.6 (44.3, 115.5) | 132.9 (67.0, 164.2) | .187 |
| Time to sustained decrease in VAS score (h) | |||
| N | 29 | 23 | |
| Mean (SD)* | 55.05 (51.03) | 77.43 (77.39) | |
| LS mean (SE)†¶ | 54.13 (12.21) | 75.65 (13.68) | .240 |
| Median (CI)ঠ| 72.0 (34.5, 115.7) | 125.3 (19.7, 180.2) | .428 |
| Time to transition to oral analgesia (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 110.35 (129.58) | 157.69 (134.71) | |
| LS mean (SE)†¶ | 108.58 (20.78) | 155.55 (23.77) | .137 |
| Median (CI)ঠ| 71.7 (48, 116.1) | 147.4 (60.9, 181.0) | .089 |
| Time to sustained decrease in VAS score and transition to oral analgesia (h) | |||
| N | 29 | 23 | |
| Mean (SD)* | 92.78 (76.07) | 137.85 (90.73) | |
| LS mean (SE)†¶ | 87.77 (15.86) | 135.17 (17.47) | .047 |
| Median (CI)ঠ| 128.0 (57.7, 156.9) | 181.0 (97.7, 217.0) | .197 |
| Time to agreement about readiness for discharge (h) | |||
| N | 38 | 28 | |
| Mean (SD)* | 100.50 (80.14) | 136.73 (122.30) | |
| LS mean (SE)†¶ | 97.63 (16.58) | 133.12 (19.46) | .165 |
| Median (CI)ঠ| 72.5 (60.9, 139.1) | 137.4 (83.2, 165.7) | .151 |
| Time to discharge (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 124.92 (129.60) | 175.27 (149.59) | |
| LS mean (SE)†¶ | 118.79 (21.73) | 173.53 (24.54) | .096 |
| Median (CI)ঠ| 72.2 (59.9, 121.0) | 156.1 (75.4, 185.8) | .092 |
| Resolution of VOC achieved at various time points cumulative, N (%) | |||
| N | 43 | 33 | |
| 48 h | 17 (39.5) | 8 (24.2) | .219 |
| 72 h | 22 (51.2) | 11 (33.3) | .162 |
| 96 h | 25 (58.1) | 13 (39.4) | .165 |
| 120 h | 28 (65.1) | 15 (45.5) | .106 |
| Hospital length of stay (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 132.36 (129.80) | 183.20 (148.26) | |
| LS mean (SE)† | 131.65 (21.50) | 182.07 (24.64) | .124 |
| Median (CI)‡ | 84.8 (66.1, 132.4) | 165.1 (79.6, 187.8) | .093 |
| VAS at discharge (cm) | |||
| N | 43 | 33 | |
| Mean (SD)* | 3.02 (2.75) | 4.03 (2.97) | |
| Median (range)* | 2.8 (0, 9.8) | 3.6 (0, 10) | |
| Cumulative parenteral opioid use (mg/kg MEU) | |||
| Mean (SD)* | 12.92 (20.8) | 57.91 (109.8) | |
| LS mean (SE)†¶ | 9.62 (11.55) | 55.59 (13.07) | .010 |
| Median (range)* | 3.42 (0.1, 93.5) | 11.17 (0, 487.3) |
| . | GMI-1070 . | Placebo . | P . |
|---|---|---|---|
| First medical evaluation to treatment (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 14.85 (4.36) | 15.35 (5.33) | |
| LS mean (SE)† | 14.54 (0.72) | 15.37 (0.82) | .445 |
| Median (CI)‡ | 14.7 (13.1, 16.6) | 15.2 (12.5, 17.3) | .457 |
| Reason for discontinuation of study drug, N (%) | |||
| N | 43 | 33 | .288§ |
| Resolution of VOC | 28 (65.1) | 19 (57.6) | |
| Received maximum (15 doses) | 6 (14) | 5 (15.2) | |
| No improvement on day 5 | 1 (2.3) | 2 (6.1) | |
| AE | 8 (18.6) | 4 (12.1) | |
| Other | 0 (0) | 3 (9.1) | |
| End point component first achieved, N (%) | |||
| N | 43 | 33 | |
| Sustained decrease in VAS score and transition to oral analgesia | 19 (44.2) | 15 (45.5) | |
| Agreement about readiness for discharge | 18 (41.9) | 16 (48.5) | |
| Hospital discharge | 8 (18.6) | 4 (12.1) | |
| Time to resolution of VOC (h) (composite end point)|| | |||
| N | 43 | 33 | |
| Mean (SD)* | 110.13 (128.04) | 147.72 (139.42) | |
| LS mean (SE)†|| | 103.64 (20.85) | 144.60 (23.54) | .192 |
| Median (CI)ঠ| 69.6 (44.3, 115.5) | 132.9 (67.0, 164.2) | .187 |
| Time to sustained decrease in VAS score (h) | |||
| N | 29 | 23 | |
| Mean (SD)* | 55.05 (51.03) | 77.43 (77.39) | |
| LS mean (SE)†¶ | 54.13 (12.21) | 75.65 (13.68) | .240 |
| Median (CI)ঠ| 72.0 (34.5, 115.7) | 125.3 (19.7, 180.2) | .428 |
| Time to transition to oral analgesia (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 110.35 (129.58) | 157.69 (134.71) | |
| LS mean (SE)†¶ | 108.58 (20.78) | 155.55 (23.77) | .137 |
| Median (CI)ঠ| 71.7 (48, 116.1) | 147.4 (60.9, 181.0) | .089 |
| Time to sustained decrease in VAS score and transition to oral analgesia (h) | |||
| N | 29 | 23 | |
| Mean (SD)* | 92.78 (76.07) | 137.85 (90.73) | |
| LS mean (SE)†¶ | 87.77 (15.86) | 135.17 (17.47) | .047 |
| Median (CI)ঠ| 128.0 (57.7, 156.9) | 181.0 (97.7, 217.0) | .197 |
| Time to agreement about readiness for discharge (h) | |||
| N | 38 | 28 | |
| Mean (SD)* | 100.50 (80.14) | 136.73 (122.30) | |
| LS mean (SE)†¶ | 97.63 (16.58) | 133.12 (19.46) | .165 |
| Median (CI)ঠ| 72.5 (60.9, 139.1) | 137.4 (83.2, 165.7) | .151 |
| Time to discharge (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 124.92 (129.60) | 175.27 (149.59) | |
| LS mean (SE)†¶ | 118.79 (21.73) | 173.53 (24.54) | .096 |
| Median (CI)ঠ| 72.2 (59.9, 121.0) | 156.1 (75.4, 185.8) | .092 |
| Resolution of VOC achieved at various time points cumulative, N (%) | |||
| N | 43 | 33 | |
| 48 h | 17 (39.5) | 8 (24.2) | .219 |
| 72 h | 22 (51.2) | 11 (33.3) | .162 |
| 96 h | 25 (58.1) | 13 (39.4) | .165 |
| 120 h | 28 (65.1) | 15 (45.5) | .106 |
| Hospital length of stay (h) | |||
| N | 43 | 33 | |
| Mean (SD)* | 132.36 (129.80) | 183.20 (148.26) | |
| LS mean (SE)† | 131.65 (21.50) | 182.07 (24.64) | .124 |
| Median (CI)‡ | 84.8 (66.1, 132.4) | 165.1 (79.6, 187.8) | .093 |
| VAS at discharge (cm) | |||
| N | 43 | 33 | |
| Mean (SD)* | 3.02 (2.75) | 4.03 (2.97) | |
| Median (range)* | 2.8 (0, 9.8) | 3.6 (0, 10) | |
| Cumulative parenteral opioid use (mg/kg MEU) | |||
| Mean (SD)* | 12.92 (20.8) | 57.91 (109.8) | |
| LS mean (SE)†¶ | 9.62 (11.55) | 55.59 (13.07) | .010 |
| Median (range)* | 3.42 (0.1, 93.5) | 11.17 (0, 487.3) |