Table 3.
Measure, Test, and Assay |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Study Name | Treatment | Trial Phase No. | Mutations | Age Group, yr | Sample Size | ppFEV1 | BMI | CFQ-R | SwCl | Conclusion (Failed or Approved) | References |
TRAFFIC/TRANSPORT (pooled results) | LUM 600 mg qd + IVA 250 mg q12 h | 3 | Homozygous F508de1 | ≥12 | 368 | +3.3% (P < 0.001) [24] | +0.28 kg/m2 (P < 0.001) [24] | +3.1 points (P = 0.007) [24] | Approved | ** | |
TRAFFIC/TRANSPORT (pooled results) | LUM 400 mg qd + IVA 250 mg q12 h | 3 | Homozygous F508de1 | ≥12 | 369 | +2.8% (P < 0.001) [24] | +0.24 kg/m2 (P < 0.001) [24] | +2.2 points (P = 0.05) [24] | |||
EVOLVE | TEZ 100 mg qd + IVA 150 mg q12 h | 3 | Homozygous F508de1 | ≥12 | 248 | +4.0% (P < 0.0001) [24] | +0.06 kg/m2 (P = 0.4127) [24] | +5.1 points (P < 0.001) [24] | (57, 58) | ||
EXPAND | TEZ 100 mg qd + IVA 150 mg q12 h | 3 | Homozygous F508de1 | ≥12 | 161 | +6.8% (P < 0.0001) [8] | +11.1 points (P < 0.0001) [8] |
http://www.glpg.com/docs/view/586fdcb9edc8a-en. Numbers within brackets indicate n.