Table 1 Baseline characteristics per treatment group (safety population)
IC43 100 μg (n = 393)No. (%) | Placebo (n = 403)No. (%) | Total (N = 796)No. (%) | |
|---|---|---|---|
Age, mean, years (min/max) | 61.8 (18/86a) | 62.0 (18/80) | 61.9 (18/86) |
Sex, no. (%) | |||
Male | 264 (67.2) | 269 (66.7) | 533 (67.0) |
Female | 129 (32.8) | 134 (33.3) | 263 (33.0) |
BMI | 28.9 | 28.5 | 28.7 |
Ethnicity, no. (%) | |||
Caucasian | 387 (98.5) | 395 (98.0) | 782 (98.2) |
Asian | 1 (0.3) | 1 (0.2) | 2 (0.3) |
Black | 4 (1.0) | 5 (1.2) | 9 (1.1) |
Other | 1 (0.3) | 2 (0.5) | 3 (0.4) |
SOFA score, mean (±SD) | 8.1 (± 2.9) | 8.3 (± 2.8) | 8.2 (± 2.8) |
APACHE II score, mean (±SD) | 18.7 (± 7.2) | 19.8 (± 7.9) | 19.2 (± 7.6) |
Medical history (reported events > 15%), no. (%) | |||
Hypertension | 220 (56.0) | 225 (55.8) | 445 (55.9) |
Pneumonia | 160 (40.7) | 162 (40.2) | 322 (40.5) |
Chronic obstructive pulmonary disease | 92 (23.4) | 105 (26.1) | 197 (24.7) |
Respiratory failure | 78 (19.8) | 91 (22.6) | 169 (21.2) |
Acute kidney injury | 76 (19.3) | 87 (21.6) | 163 (20.5) |
Atrial fibrillation | 72 (18.3) | 82 (20.3) | 154 (19.3) |
Obesity | 71 (18.1) | 69 (17.1) | 140 (17.6) |
Sepsis | 70 (17.8) | 52 (12.9) | 122 (15.3) |
Diabetes mellitus | 68 (17.3) | 66 (16.4) | 134 (16.8) |
Septic shock | 63 (16.0) | 72 (17.9) | 135 (17.0) |
Anemia | 59 (15.0) | 72 (17.9) | 131 (16.5) |
Hypotension | 57 (14.5) | 69 (17.1) | 126 (15.8) |
Prior medicationb | |||
Antibacterials for systemic use | 177 (45.0) | 184 (45.7) | 361 (45.4) |
Antidiarrheals, intestinal anti-inflammatories | 16 (4.1) | 12 (3.0) | 28 (3.5) |
Antimycobacterials | 7 (1.8) | 8 (2.0) | 15 (1.9) |