Methods
- Patients in SENSCIS-ON came from two parent trials:
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- We analyzed changes in FVC (in mL and based on proposed thresholds for minimal clinically important differences2), adverse events, dose adjustments, and permanent treatment discontinuations over 52 weeks in SENSCIS-ON in:
- Patients who had received nintedanib in the SENSCIS trial and continued nintedanib in SENSCIS-ON (“continued nintedanib” group)
- Patients who had received placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON, or who had received nintedanib for a short period in the drug-drug interaction study (“initiated nintedanib” group).