Table 8.
Composite or other potential covariate interactions
Composite or Interactions | Definition |
Baseline BODE | BMI, FEV1% predicted, MMRC, 6 MWT Composite Score |
NETT Strata | Randomization Stratification by Baseline Cycle Ergometry and HRCT at TLC |
NETT Strata by Right vs. Left | Randomization Stratification by Baseline Cycle Ergometry and HRCT at TLC, by Right or Left Lung |
Lobar Exclusion by Fissure Interaction* | Fissure Score = 3 AND Lobar Exclusion = Yes vs. all others |
Lobar Exclusion, Fissure, and RV % Predicted* | Lobar Exclusion = Yes AND Fissure Score = 3 AND RV % Predicted ≥ 200% vs. all others |
Lobar Exclusion, Fissure, and RV % Predicted* | Lobar Exclusion = Yes AND Fissure Score = 3 AND RV % Predicted ≥ 200% vs. all others |
Large Valve by Right vs. Left* | Right vs. Left Lung AND Large Only vs. Others |
Small Valve by Right vs. Left* | Right vs. Left Lung AND Small Only vs. Others |
Expectorated Valve Replaced* | Valve(s) Expectorated AND Lobar Exclusion = Yes vs. all others |
Expectorated Valve Not Replaced* | Valve(s) Expectorated AND Lobar Exclusion = No vs. all others |
Lobar Exclusion by Site* | Technical Success by Site |
First Case by Site* | First Treatment Case by Site vs. All Others |
Learning Curve by Site* | Experience Level: Case 1, vs. 2 & 3, vs. 4–6, vs. 7–9, vs. ≥10 by site. |
*These potential covariates apply only to the treatment arm and do not have a control arm subset.