TABLE 1.
STUDY POPULATION, CLINICAL TRIAL PARTICIPANTS COMPARED WITH NONPARTICIPANTS
| Characteristic | Trial Participants | Trial Nonparticipants | p |
|---|---|---|---|
| n | 2,635 | 6,100 | |
| Age, mean (± SD) | 16.6 (9.2) | 15.1 (8.4) | < 0.01 |
| Sex, n (% female) | 1,233 (47) | 2,810 (46) | 0.53 |
| Genotype | |||
| Homozygous for Δ F508, n (%) | 983 (54) | 1,961 (54) | < 0.01 |
| Heterozygous for Δ F508, n (%) | 681 (38) | 1,299 (36) | < 0.01 |
| Nonwhite, n (%) | 49 (2) | 220 (4) | < 0.01 |
| Commercial health insurance, n (%) | 1,532 (58) | 3,218 (53) | < 0.01 |
| Mean height percentile (SD) | 34.5% (26.8) | 33.7% (26.7) | 0.21 |
| Median weight percentile (interquartile range) | 19.0% (6,45) | 23.0% (7,48) | < 0.001 |
| FEV1, L, mean (± SD) | 1.69 (0.80) | 1.83 (0.86) | < 0.001 |
| FEV1% predicted (mean ± SD) | 68% (26) | 77% (25) | < 0.001 |
| FVC, L, mean (± SD) | 2.41 (1.09) | 2.46 (1.15) | 0.06 |
| FVC % predicted, mean (± SD) | 81% (22) | 88% (22) | < 0.001 |
| Pancreatic insufficiency, n (%) | 2,488 (95) | 5,728 (94) | 0.27 |
| Median annual outpatient visits in 1992 (interquartile range) | 5 (3–10) | 4 (2–5) | < 0.001 |
| Colonized by Pseudomonas aeruginosa, n (%) | 1,710 (71) | 3,216 (65) | < 0.01 |
| Colonized by Burkholderia cepacia, n (%) | 72 (3) | 112 (2.1) | 0.025 |
Characteristics were assessed at cohort entry. Total population: n = 8,735.