Table 1.
Subject Demographics and Baseline Characteristics—Safety Analysis Set
| Parameter | Overall IV (N = 148) | Overall Oral (N = 134) | Total (N = 158) |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 43 a | 21 b | 64 (40.5) |
| Male | 60 a | 34 b | 94 (59.5) |
| Age, y | |||
| Mean (SD) | 32.5 (7.7) | 32.2 (7.8) | 32.5 (7.7) |
| Median (range) | 33.0 (18–45) | 32.0 (18–45) | 32.5 (18–45) |
| Race, n (%) | |||
| White | 97 a | 49 b | 146 (92.4) |
| Black | 3 a | 3 b | 6 (3.8) |
| Asian | 3 a | 1 b | 4 (2.5) |
| Other | 0 a | 2 b | 2 (1.3) |
| Weight, kg | |||
| Mean (SD) | 74.8 (12.2) | 76.0 (12.5) | 75.1 (12.4) |
| Median (range) | 76.7 (50.3–113.2) | 78.6 (50.3–113.2) | 77.5 (50.3–113.2) |
| Height, cm | |||
| Mean (SD) | 174.1 (9.2) | 174.7 (9.4) | 174.3 (9.2) |
| Median (range) | 174.5 (152–198) | 176.0 (152–198) | 175.0 (152–198) |
| BMI, kg/m2 | |||
| Mean (SD) | 24.6 (2.6) | 24.8 (2.6) | 24.6 (2.6) |
| Median (range) | 24.8 (18.8–29.4 c ) | 25.2 (19.3–29.4 c ) | 24.8 (18.8–29.4 c ) |
BMI, body mass index; IV, intravenous infusion of 17.6 to 353 mg fosnetupitant and administration of placebo capsule; Oral, oral NEPA (netupitant 300 mg/palonosetron 0.5 mg) administration and placebo infusion; SD, standard deviation.
a
Group of subjects that received: IV treatment – oral treatment or IV treatment, depending on cohort (n = 103).
b
Group of subjects that received: oral treatment – IV treatment or oral treatment, depending on cohort (n = 55).
c
Acceptance window for upper limit of BMI: 29.0–29.4 kg/m2.