Table 5 Incidence of diarrhea in the 100 mg BID treatment group and the 150 mg BID treatment group, optimally matched by nintedanib plasma exposure (observed and predicted Cpre,ss at starting dose level) in IPF trials (TOMORROW, INPULSIS-1 and INPULSIS-2)
From: Exposure–safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease
100 mg BID | 150 mg BID (optimally matched by predicted Cpre,ss) | ||||||
|---|---|---|---|---|---|---|---|
No diarrhea | Diarrhea event | No diarrhea | Diarrhea event | ||||
N | % | N | % | N | % | N | % |
54 | 62.8 | 32 | 37.2 | 65 | 37.8 | 107 | 62.2 |
100 mg BID | 150 mg BID (optimally matched by observed Cpre,ss) | ||||||
|---|---|---|---|---|---|---|---|
No diarrhea | Diarrhea event | No diarrhea | Diarrhea event | ||||
N | % | N | % | N | % | N | % |
50 | 62.5 | 30 | 37.5 | 66 | 41.3 | 94 | 58.8 |