Table 1.
Demographic and Baseline Clinical Characteristics
| EPIC Clinical Trial (N=304) | ESCF Historical Controls (N=608) | ||
|---|---|---|---|
| Gender, n (%) | |||
| Female | 154 (50.7) | 308 (50.7) | |
| Race*, n (%) | |||
| White (non-Hispanic) | 285 (93.8) | 544 (89.5) | |
| Black (non-Hispanic) | 7 (2.3) | 19 (3.1) | |
| Hispanic | 4 (1.3) | 32 (5.3) | |
| Other/Mixed/Unknown | 8 (2.6) | 13 (2.1) | |
| Genotype, n (%) | |||
| Delta F508 Homozygous | 149 (49.0) | 266 (43.8) | |
| Delta F508 Heterozygous | 116 (38.2) | 165 (27.1) | |
| Other | 24 (7.9) | 30 (4.9) | |
| Unknown | 15 (4.9) | 147 (24.2) | |
| Age at New Onset Pa, yrs | |||
| Mean (SD) | 5.5 (3.5) | 5.5 (3.5) | |
| Min, Max | 0.1, 13.0 | 0.50, 12.96 | |
| Age Group, years, n (%) | |||
| 1-3 | 93 (30.6) | 189 (31.1) | |
| >3-6 | 91 (29.9) | 174 (28.6) | |
| >6-12 | 120 (39.5) | 245 (40.3) | |
| FEV1 (% Predicted)†* | |||
| n | 155 | 230 | |
| Mean (SD) | 96.2 (16.7) | 90.9 (18.3) | |
| Min, Max | 28.9, 130.5 | 26.9, 142.7 | |
*
p<0.05
†
Spirometry measures are only available for those old enough to perform the procedure and corresponded to the closest visit on or after new onset Pa.