Table 1.
Patient demographics and baseline characteristics (ITT and PP populations)
| Characteristic | ITT |
PP |
||
|---|---|---|---|---|
| moxifloxacin (N = 426) | TZP–AMC (N = 377) | moxifloxacin (N = 361) | TZP–AMC (N = 307) | |
| Sex, male, n (%) | 267 (62.7) | 255 (67.6) | 229 (63.4) | 213 (69.4) |
| Mean (SD) age, years | 53.4 (16.2) | 52.8 (16.0) | 52.7 (16.4) | 51.8 (15.9) |
| Mean (SD) body mass index, kg/m2 | 28.2 (6.4) | 27.0 (5.0) | 27.8 (6.0) | 27.0 (4.9) |
| Mean (range) temperature, °C | 39.2 (36.4–41.5) | 39.2 (36.5–42.0) | 39.2 (36.7–41.5) | 39.2 (36.5–42.0) |
| Mean (SD) white blood cells, Giga/L | 10.8 (4.8) | 10.0 (3.9) | 10.9 (4.8) | 10.2 (3.9) |
| Mean (SD) HbA1c, % | 7.3 (2.5) | 7.0 (2.2) | 7.4 (2.6) | 7.0 (2.2) |
| Mean (SD) C-reactive protein, mg/L | 9.0 (9.1) | 8.7 (8.9) | 9.0 (8.9) | 8.9 (8.9) |
| Co-morbid condition, n (%) | ||||
| cardiac | 101 (23.7) | 81 (21.5) | 81 (22.4) | 60 (19.5) |
| malignancy | 7 (1.6) | 6 (1.6) | 5 (1.4) | 4 (1.3) |
| diabetes mellitus | 180 (42.3) | 136 (36.1) | 156 (43.2) | 113 (36.8) |
| hepatic | 7 (1.6) | 13 (3.4) | 6 (1.7) | 9 (2.9) |
| renal | 21 (4.9) | 21 (5.6) | 18 (5.0) | 15 (4.9) |
| respiratory | 21 (4.9) | 23 (6.1) | 17 (4.7) | 18 (5.9) |
| transplantation | 0 | 1 (0.3) | 0 | 1 (0.3) |
| vascular | 124 (29.1) | 119 (31.6) | 106 (29.4) | 89 (29.0) |
HbA1c, glycosylated haemoglobin.