Table 3.
Clinical Response by age group and overall
| Age Group |
Total N=123 | |||
|---|---|---|---|---|
| < 18 N=43 | ≥ 18 N=80 | |||
| Short Term Treatment Response | ||||
| Improvement in symptom score[1] | n | 36 | 57 | 93 |
| mean (SD) | −21.7 (13.9) | −22.2 (14.9) | −22.0 (14.4) | |
| Change in FEV1 (% predicted)[2] | n | 35 | 65 | 100 |
| mean (SD) | 13.9 (9.2) | 8.0 (8.3) | 10.0 (9.1) | |
| < 10% improvement FEV1 (L)[3] | n (%) | 10 (28.6) | 23 (35.4) | 33 (33.0) |
| IV antibiotic within 30 days of completing IV for study PE[4] | n (%) | 2 (4.7) | 9 (11.3) | 11 (8.9) |
| Interim Response: 3 months post study PE | ||||
| Change in best FEV1 (% predicted) | n | 37 | 71 | 108 |
| from 6 mos prior to 3 mos post PE | mean (SD) | 1.6 (12.4) | 2.5 (7.9) | 2.2 (9.6) |
| < 90% FEV1 baseline recovery[5] | n (%) | 5 (13.5) | 8 (11.3) | 13 (12.0) |
| IV antibiotic within 90 days of completing IV for study PE[4] | n (%) | 10 (23.3) | 30 (37.5) | 40 (32.5) |
| Long Term Response: | ||||
| IV antibiotic within 180 days of completing IV for study PE | n (%) | 23 (53.5) | 48 (60.0) | 71 (57.7) |
| Time to next IV antibiotic[4](days) | mean (SD) | 236.5 (190.3) | 234.7 (235.9) | 235.3 (220.2) |
| median | 174.0 | 139.0 | 143.0 | |
| min, Max | 22.0, 740.0 | 10.0, 984.0 | 10.0, 984.0 | |
[1]
Improvement in CF Respiratory Infection Symptom Score (CRISS) during treatment for study PE
[2]
Absolute change in percent predicted during study PE treatment from visit 1 to visit 2
[3]
<10% relative change in FEV1 (L) during study PE treatment (N=100, n<18=35, n≥18=65)
[4]
Only IV antibiotic episodes occurring 7 or more days after end of treatment for study PE are considered
[5]
Best FEV1 (% predicted) 3 months post study PE < 0.90 of best FEV1 (% predicted) 6 months prior to study PE4 (N=108, n<18=37, n≥18=71)