Table 3.
Baseline Data of the Single Dose Trial Populations (Full Analysis Set)
| Tapentadol Oral Solution Single Dose Trial | Tapentadol Intravenous Single Dose Trial | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Age Group | 6 m to <2 y (N=8) | 1 to <6 m (N=6) | Birth to <1 m (N=5) | Total (N=19) | 6 m to <2 y (N=10) | 1 to <6 m (N=11) | Birth to <1 m (N=9) | Preterm Neonates (N=8) | Total (N=38) |
| Sex | |||||||||
| Female | 4 (50%) | 2 (33.3%) | 3 (60%) | 9 (47.4%) | 0 | 4 (36.4%) | 2 (22.2%) | 4 (50%) | 10 (26.3%) |
| Male | 4 (50%) | 4 (66.7%) | 2 (40%) | 10 (52.6%) | 10 (100%) | 7 (63.6%) | 7 (77.8%) | 4 (50%) | 28 (73.7%) |
| Age (days) | 420±147.8 | 92.8±37.9 | 14.6±8.5 | 210±209 | 423.0±158.4 | 95.2±41.8 | 15.3±6.4 | 35±37.7 | 149.9±187.5 |
| Weight (kg) | 9.2 ±1.5 | 5.9±1.2 | 3.8±0.7 | 6.7±2.6 | 11.2±2.2 | 6.4±1.6 | 3.7±0.6 | 2.5±0.8 | 6.2±3.6 |
| BMI (kg/m2) | 17.1±1.4 | 15.3±1.3 | 13.4±2.5 | 15.6±2.2 | 16.5±1.5 | 16.0±1.9 | 12.8±1.3 | 10.4±2.1 | 14.2±2.9 |
Note: Data are number of patients (%) or mean ± standard deviation.
Abbreviations: BMI, body mass index; m, months; y, years.