Table 1.
Baseline Characteristics.
| High dose XY2405 | Medium dose XY2405 | Low dose XY2405 | All doses XY2405 combined | Placebo | |
|---|---|---|---|---|---|
| Patients randomised: n | 57 | 56 | 58 | 171 | 57 |
| Age: | |||||
| mean (SD) | 35.9 (14.0) | 37.6 (14.3) | 35.5 (13.8) | 36.3 (14.0) | 36.4 (14.3) |
| median (min -- max) | 33 (19 -- 65) | 37 (18 -- 64) | 32 (17 -- 61) | 34 (17 -- 65) | 34 (17 -- 64) |
| 16 -- 39 (%) | 36 (63.2) | 32 (57.1) | 35 (60.3) | 103 (60.2) | 35 (61.4) |
| 40 -- 49 (%) | 8 (14.0) | 11 (19.6) | 9 (15.5) | 28 (16.4) | 8 (14.0) |
| 50 + (%) | 13 (22.8) | 13 (23.2) | 14 (24.1) | 40 (23.4) | 14 (24.6) |
| Gender: n (%) | |||||
| male | 51 (89.5) | 50 (89.3) | 52 (89.7) | 153 (89.5) | 50 (87.7) |
| Time since injury: | |||||
| mean (SD) | 5.5 (1.7) | 5.7 (1.9) | 5.8 (1.8)*** | 5.7 (1.8) | 5.9 (1.6) |
| median (min -- max) | 5.8 (1.4 -- 8.0) | 5.8 (2.1 -- 10.8)* | 5.8 (1.8 -- 8.6)* | 5.8 (1.4 -- 10.8)* | 6.2 (2.3 -- 8.0) |
| ≤ 1 hr (%) | 0 | 0 | 0 | 0 | 0 |
| > 1hr - ≤ 3 hrs (%) | 4 (7.0) | 3 (5.4) | 5 (8.6) | 12 (7.0) | 4 (7.0) |
| > 3hrs - ≤ 8 hrs (%) | 53 (93.0) | 52 (92.9) | 50 (86.2) | 155 (90.6) | 53 (93.0) |
| > 8 hrs (%) | 0 | 1 (1.8) | 2 (3.4) | 3 (1.8) | 0 |
| Glasgow Coma Score: | |||||
| mean (SD) | 7.4 (3.0) | 7.7 (3.4) | 7.6 (2.9) | 7.6 (3.1) | 7.5 (3.0) |
| median (min-max) | 7 (3 -- 14)** | 7 (3 -- 15)** | 7 (3 -- 12) | 7 (3 -- 15)** | 8 (3 -- 12) |
| 3 -- 5 (%) | 17 (29.8) | 15 (26.8) | 17 (29.3) | 49 (28.7) | 18 (31.6) |
| 6 -- 8 (%) | 18 (31.6) | 19 (33.9) | 17 (29.3) | 54 (31.6) | 17 (29.8) |
| 9 -- 12 (%) | 21 (36.8) | 21 (37.5) | 24 (41.4) | 66 (38.6) | 22 (38.6) |
| >12 (%) | 1 (1.8) | 1 (1.8) | 0 | 2 (1.2) | 0 |
| Glasgow Coma Motor Sub-score: n | |||||
| mean (SD) | 3.8 (1.5) | 3.9 (1.8) | 4.1 (1.5)*** | 3.9 (1.6) | 4.0 (1.7) |
| median (min-max) | 4 (1 -- 6) | 5 (1 -- 6) | 5 (1 -- 6) | 5 (1 -- 6) | 5 (1 -- 6) |
| Pupil reactivity to light: n (%) | |||||
| Not testable (%) | 0 | 0 | 0 | 0 | 0 |
| Neither (%) | 11 (19.3) | 6 (10.7) | 4 (6.9) | 21 (12.3) | 6 (10.5) |
| Only one reactive (%) | 3 (5.3) | 8 (14.3) | 11 (19.0) | 22 (12.9) | 7 (12.3) |
| Both reactive (%) | 43 (75.4) | 42 (75.0) | 43 (74.1) | 128 (74.9) | 44 (77.2) |
| Body Mass Index: | |||||
| mean (SD) | 24.5 (4.0) | 24.0 (2.8) | 24.0 (3.1)*** | 24.2 (3.3) | 24.9 (2.9) |
| median (min-max) | 24.2 (17.3 -- 39.4) | 24.2 (18.1 -- 31.1) | 23.4 (17.3-33.2) | 23.9 (17.3 -- 39.4) | 24.4 (19.7-34.6) |
| Temperature: | |||||
| mean (SD) | 36.7 (0.8)# | 36.6 (0.7)# | 36.6 (0.8)# | 36.6 (0.8)# | 36.6 (0.9)# |
| median (min-max) | 36.9 (34.0 -- 38.9) | 36.7 (33.7 -- 37.8) | 36.8 (33.7 -- 38.3) | 36.8 (33.7 -- 38.9) | 36.8 (33.5 -- 39.4) |
| Systolic Blood Pressure: | |||||
| mean (SD) | 132.6 (26.7) | 128.0 (21.4) | 130.4 (20.6)*** | 130.3 (23.0) | 124.7 (22.7) |
| median (min-max) | 130.0 (98.0-212.0) | 130.0 (91.0-200.0) | 129.0 (93.0-190.0) | 130.0 (91.0-212.0) | 125.0 (60.0-177.0) |
* Three individuals had their first injection after 8 hours
** Two individuals had Glasgow coma scores >12 but fulfilled all other eligibility criteria. As per protocol (6.5.2) a waiver was granted to allow these individuals to be randomised.
*** 1 missing value for low dose
# 3 missing values for high dose, 2 missing values for medium dose, 1 missing value for low dose, 1 missing value for placebo