Table 1.
Key Baseline Characteristics for Patients Receiving LUM 400 mg q12h/IVA 250 mg q12h or Placebo by Change in ppFEV1 Threshold Category
| LUM 400 mg q12h/IVA 250 mg q12h |
|||||
|---|---|---|---|---|---|
| Placebo (n=371) |
Absolute change ≤0 (n=146) |
Absolute change >0 (n=223) |
Relative change <5% (n=228) |
Relative change ≥5% (n=141) |
|
| Female sex, n (%) | 181 (48.8) | 73 (50.0) | 109 (48.9) | 110 (48.2) | 72 (51.1) |
| Age group, n (%), y | |||||
| 12 to <18 | 96 (25.9) | 34 (23.3) | 64 (28.7) | 59 (25.9) | 39 (27.7) |
| ≥18 | 275 (74.1) | 112 (76.7) | 159 (71.3) | 169 (74.1) | 102 (72.3) |
| Baseline ppFEV1 subgroup, n (%)* | |||||
| <40 | 28 (7.5) | 8 (5.5) | 21 (9.4) | 13 (5.7) | 16 (11.3) |
| ≥40 | 338 (91.1) | 134 (91.8) | 202 (90.6) | 211 (92.5) | 125 (88.7) |
| Inhaled antibiotic use before first dose, n (%)† | 258 (69.5) | 90 (61.6) | 135 (60.5) | 137 (60.1) | 88 (62.4) |
| Inhaled hypertonic saline before first dose, n (%)† | 220 (59.3) | 89 (61.0) | 138 (61.9) | 140 (61.4) | 87 (61.7) |
| Use of dornase alfa before first dose, n (%)† | 281 (75.7) | 107 (73.3) | 166 (74.4) | 165 (72.4) | 108 (76.6) |
| P aeruginosa positive, n (%) | 276 (74.4) | 120 (82.2) | 166 (74.4) | 179 (78.5) | 107 (75.9) |
IVA, ivacaftor; LUM, lumacaftor; P aeruginosa, Pseudomonas aeruginosa; ppFEV1, percent predicted forced expiratory volume in 1 second; q12h, every 12 hours.
*
For patients in whom a ppFEV1 measure was available before the first dose of study drug.
†
Includes medication received before the first dose of study drug; patients may or may not have continued to receive the medication at the time the first dose was administered.