Table 5.
Baseline Demographic and Clinical Characteristics of Intention-to-Treat Population
| Treatment Group | Overall (n=124) | |||
|---|---|---|---|---|
| Placebo (n=42) | C1-INH 10 U/kg (n=39) | C1-INH 20 U/kg (n=43) | ||
| Gender, n (%) | ||||
| Female | 28 (66.7) | 26 (66.7) | 30 (69.8) | 84 (67.7) |
| Male | 14 (33.3) | 13 (33.3) | 13 (30.2) | 40 (32.3) |
| Age, years | ||||
| Mean (SD) | 31.5 (13.57) | 33.1 (12.77) | 34.6 (14.91) | 33.1 (13.76) |
| Range | 6 – 62 | 13 – 72 | 10 – 71 | 6 – 72 |
| Race/ethnic group, n (%) | ||||
| American Indian/Alaskan Native | 1 (2.4) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Asian | 2 (4.8) | 1 (2.6) | 0 (0.0) | 3 (2.4) |
| Black | 1 (2.4) | 0 (0.0) | 3 (7.0) | 4 (3.2) |
| Hispanic | 1 (2.4) | 2 (5.1) | 2 (4.7) | 5 (4.0) |
| White | 37 (88.1) | 36 (92.3) | 38 (88.4) | 111 (89.5) |
| BMI, kg/m2 | ||||
| Mean (SD) | 25.3 (6.00) | 26.7 (5.29) | 27.0 (5.57) | 26.4 (5.64) |
| Range | 13 – 38 | 17 – 36 | 18 – 40 | 13 – 40 |
| HAE type, n (%) | ||||
| Type I | 38 (90.5) | 35 (89.7) | 35 (81.4) | 108 (87.1) |
| Type II | 4 (9.5) | 3 (7.7) | 8 (18.6) | 15 (12.1) |
| Missing | 0 (0.0) | 1 (2.6) | 0 (0.0) | 1 (0.8) |
| Intensity of baseline attack, n (%) | ||||
| Moderate | 26 (61.9 | 32 (82.1) | 27 (62.8) | 85 (68.5) |
| Severe | 16 (38.1) | 7 (17.9) | 16 (37.2) | 39 (31.5) |
BMI=body mass index; HAE=hereditary angioedema; SD=standard deviation
Source: Adapted from Craig 2009b.