The adjusted annual rate of change in FVC was -114.7 ml with nintedanib versus -239.9 ml with placebo ( difference , 125.3 ml ; 95 % confidence interval [ CI ] , 77.7 to 172.8 ; P < 0.001 ) in INPULSIS-1 and -113.6 ml with nintedanib versus -207.3 ml with placebo ( difference , 93.7 ml ; 95 % CI , 44.8 to 142.7 ; P < 0.001 ) in INPULSIS-2 .