Table 6.
Baseline Data of the Multiple Dose Trial Population (Full Analysis Set)
| Placebo N=4 | Tapentadol N=11 | Overall N=15 | |
|---|---|---|---|
| Sex | |||
| Female | 2 (50%) | 6 (54.5%) | 8 (53.3%) |
| Male | 2 (50%) | 5 (45.5%) | 7 (46.7%) |
| Age group | |||
| Birth to <30 days | 1 (25%) | 2 (18.2%) | 3 (20%) |
| 30 days to <6 months | 1 (25%) | 2 (18.2%) | 3 (20%) |
| 6 months to <2 years | 2 (50%) | 7 (63.6%) | 9 (60%) |
| Weight (kg) | 6.6±3.3 | 8.0±2.6 | 7.6±2.7 |
| Body mass index (kg/m2) | 14.7±2.3 | 15.0±2.1 | 14.9±2.1 |
| Duration of surgery (min) | 136 (115–170) | 105 (30–151) | 110 (30–170) |
| Background infusiona | 4 (100%) | 7 (63.6%) | 11 (73.3%) |
| Intake of morphine or hydromorphone in the 24 h prior to trial medication (mg/kgb) | 0.3 (0.2–0.4) | 0.2 (0.0c-0.8) | 0.24 (0.0c-0.8) |
| Time between end of surgery and first dose of trial medication (min) | 2365.5 (1020–3435) | 511.8 (259.8–2059.8) | 1234.2 (259.8–3435) |
Notes: Data are mean ± standard deviation, number of patients (%), or median (range). aMorphine or hydromorphone; bMorphine equivalents; cIntake of one patient was below 0.01, result was rounded to 0.0.