Table 2 Baseline demographic and disease characteristics (safety population)
AZD9773 cohort 1 (50 U/kg) (n= 8) | AZD9773 cohort 2 (250 U/kg) (n= 9) | AZD9773 cohort 3 (250/50 U/kg) (n= 12) | AZD9773 cohort 4 (500/100 U/kg) (n= 10) | AZD9773 cohort 5 (750/250 U/kg) (n= 8) | Placebo (n= 23) | Total (n= 70) | |
|---|---|---|---|---|---|---|---|
Mean age ± SD, years | 53.0 ± 11.8 | 49.7 ± 15.0 | 55.1 ± 10.8 | 53.0 ± 17.9 | 63.5 ± 16.1 | 58.9 ± 17.4 | 56.1 ± 15.5 |
Male:female, n | 6:2 | 5:4 | 5:7 | 3:7 | 2:6 | 11:12 | 32:38 |
Race, n (%) | |||||||
Caucasian/white | 7 (87.5) | 8 (88.9) | 11 (91.7) | 9 (90.0) | 7 (87.5) | 20 (87.0) | 62 (88.6) |
Black/African American | 1 (12.5) | 1 (11.1) | 1 (8.3) | 0 | 1 (12.5) | 2 (8.7) | 6 (8.6) |
Other | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (4.3) | 2 (2.9) |
Shock, n (%) | |||||||
Yes | 5 (62.5) | 6 (66.7) | 9 (75.0) | 9 (90.0) | 7 (87.5) | 20 (87.0) | 56 (80.0) |
No | 3 (37.5) | 3 (33.3) | 3 (25.0) | 1 (10.0) | 1 (12.5) | 3 (13.0) | 14 (20.0) |
On ventilator, n (%)* | |||||||
Yes | 7 (87.5) | 8 (100.0) | 9 (81.8) | 8 (88.9) | 8 (100.0) | 20 (87.0) | 60 (89.6) |
No | 1 (12.5) | 0 | 2 (18.2) | 1 (11.1) | 0 | 3 (13.0) | 7 (10.4) |
Missing | 0 | 1 | 1 | 1 | 0 | 0 | 3 |
Shock + ventilator, n (%)* | 4 (50.0) | 5 (55.6) | 7 (58.3) | 7 (70.0) | 7 (87.5) | 17 (73.9) | 47 (67.1) |
Organ failures, n (%)** | |||||||
0 | 1 (12.5) | 0 | 1 (8.3) | 0 | 0 | 0 | 2 (2.9) |
1 | 0 | 0 | 2 (16.7) | 2 (20.0) | 2 (25.0) | 1 (4.3) | 7 (10.0) |
2 | 2 (25.0) | 3 (33.3) | 2 (16.7) | 1 (10.0) | 1 (12.5) | 5 (21.7) | 14 (20.0) |
3 | 3 (37.5) | 4 (44.4) | 3 (25.0) | 3 (30.0) | 1 (12.5) | 9 (39.1) | 23 (32.9) |
≥ 4 | 2 (25.0) | 2 (22.2) | 4 (33.3) | 4 (40.0) | 4 (50.0) | 8 (34.8) | 24 (34.3) |
APACHE II score | ( n = 8) | ( n = 9) | ( n = 12) | ( n = 10) | ( n = 7) | ( n = 22) | ( n = 68) |
Mean ± SD | 28.4 ± 10.3 | 25.1 ± 7.8 | 26.3 ± 11.1 | 22.9 ± 9.0 | 25.1 ± 8.8 | 26.6 ± 8.0 | 25.9 ± 8.9 |
SOFA score | ( n = 7) | ( n = 8) | ( n = 7) | ( n = 8) | ( n = 6) | ( n = 20) | ( n = 56) |
Mean ± SD | 11.9 ± 4.3 | 10.9 ± 3.6 | 10.4 ± 3.4 | 11.5 ± 2.6 | 10.3 ± 3.6 | 10.7 ± 3.0 | 11.0 ± 3.2 |
TNF-α concentration, pg/mL | ( n = 8) | ( n = 8) | ( n = 9) | ( n = 9) | ( n = 8) | ( n = 23) | ( n = 65) |
Median (range) | 4.7 (1.3 to 48.8) | 9.8 (2.7 to 54.3) | 3.6 (1.3 to 14.2) | 3.7 (1.3 to 8.2) | 5.8 (1.3 to 18.3) | 5.0 (1.6 to 61.7) | 5.2 (1.3 to 61.7) |
IL-6 concentration, pg/mL | ( n = 7) | ( n = 7) | ( n = 9) | ( n = 8) | ( n = 7) | ( n = 19) | ( n = 57) |
Median (range) | 465 (18 to 23,733) | 189 (47 to 85,183) | 215 (24 to 13,849) | 1403 (135 to 16,168) | 336 (194 to 94,207) | 454 (28 to 153,600) | 336 (18 to 153,600) |
Procalcitonin level, ng/mL | ( n = 8) | ( n = 8) | ( n = 10) | ( n = 10) | ( n = 6) | ( n = 23) | ( n = 65) |
Median (range) | 28.5 (1.8 to 456.4) | 4.8 (0.3 to 250.9) | 4.0 (0.3 to 800.3) | 16.5 (1.3 to 89.6) | 15.1 (2.5 to 17.1) | 14.7 (0.3 to 328.5) | 14.2 (0.3 to 800.3) |
> 0.5 ng/mL, n (%) | 8 (100) | 7 (87.5) | 7 (70.0) | 10 (100) | 6 (100) | 22 (95.7) | 60 (92.3) |
Total fluid volume in 24 h prior to randomization, mL/kg | ( n = 8) | ( n = 9) | ( n = 11) | ( n = 7) | ( n = 8) | ( n = 23) | ( n = 66) |
Median (range) | 51.7 (23.8 to 167.6) | 58.0 (6.4 to 158.6) | 40.1 (11.1 to 183.4) | 34.0 (17.2 to 196.8) | 58.5 (29.3 to 434.1) | 58.4 (8.7 to 373.5) | 56.4 (6.4 to 434.1) |
Relevant medical history, n (%)† | |||||||
Diabetes | 1 (12.5) | 4 (44.4) | 4 (33.3) | 3 (30.0) | 3 (37.5) | 7 (30.4) | 22 (31.4) |
COPD | 3 (37.5) | 2 (22.2) | 2 (16.7) | 2 (20.0) | 3 (37.5) | 4 (17.4) | 16 (22.9) |
Chronic renal failure | 1 (12.5) | 2 (22.2) | 0 | 1 (10.0) | 0 | 0 | 4 (5.7) |
Colon cancer | 0 | 0 | 0 | 0 | 1 (12.5) | 1 (4.3) | 2 (2.9) |