TABLE 2

Change in FVC (mL) from baseline of INPULSIS®-ON at week 48 in patients whose FVC improved or did not decline in INPULSIS® and in patients whose FVC declined in INPULSIS® (based on the annual rate of change in INPULSIS®)

Patients treated with nintedanib in INPULSIS®Patients treated with placebo in INPULSIS®
Improvement/no decline in FVC in INPULSIS®Decline in FVC in INPULSIS®Improvement or no decline in FVC in INPULSIS®Decline in FVC in INPULSIS®
nMean±sdnMean±sdnMean±sdnMean±sd
Subjects N15848038385
FVC at baseline of INPULSIS®-ON mL1402913±8062902480±732283203±10032762568±813
Change in FVC from baseline of INPULSIS®-ON mL      
 Week 213428±1412826±1452833±167268−2±145
 Week 413611±1622749±14428−20±199263−11±156
 Week 613213±2122768±14727−23±200260−24±176
 Week 121370±192271−14±17427−25±129257−23±187
 Week 24130−35±204262−48±183257±157241−35±204
 Week 36125−30±197250−80±21326−38±214224−45±225
 Week 48119−70±246233−110±23124−45±226209−76±246

FVC: forced vital capacity. #: all patients were treated with open-label nintedanib in INPULSIS®-ON.