Supplementary Table 1 Summary of clinical trials included in the population pharmacokinetic analysis Subjects Subjects Starting doses Trial name Study Population randomized to included in Pharmacokinetic sampling dose (mg) used (mg) nintedanib, n analysis, n TOMORROW [1] IPF; diagnosis 343 342 50 qd, 50, 0a Pre-dose: days 1, 29, 169, 365 ≤5 years prior to 100, 150 bid and end-of-trialc screening visit Post-dose: day 1 and day 29 at 2 (1-3) h after dosing; day 169 and end-of-trialc at 2 (1-3) and 7 (4-10) h after dosing INPULSIS-1 [2] IPF; diagnosis 309 285 150 bid 100 bidb Pre-dose: days 29 and 169 ≤5 prior to Post-dose only): days 29 screening visit and 169 at 2-4 h after dosing INPULSIS-2 [2] IPF; diagnosis 329 306 150 bid 100 bidb Pre-dose: days 29 and 169 ≤5 years prior to Post-dose (Japan only): days 29 screening visit and 169 at 2-4 h after dosing qd, once daily; bid, twice daily; IPF, idiopathic pulmonary fibrosis a Treatment interruptions or 1-step dose reductions to manage adverse events were allowed: by 50 mg qd for subjects in the 50 mg qd or 50 mg bid and by 50 mg bid for those in the 100 mg bid or 150 mg bid group. No dose reescalation was allowed. b Treatment interruptions or 1-step dose reductions to manage adverse events were allowed: by 50 mg bid to 100 mg bid and then increased again to 150 mg bid after recovery. c End-of trial was day 365 unless a patient discontinued, in which case samples were taken on the day of discontinuation.
Supplementary Table 1 Summary of clinical trials included in the population pharmacokinetic analysis Trial name Study Population Subjects randomized to nintedanib, n Subjects included in analysis, n Starting dose (mg) doses used (mg) Pharmacokinetic sampling TOMORROW [1] IPF; diagnosis ≤5 years prior to screening visit 343 342 50 qd, 50, 100, 150 bid 0a Pre-dose: days 1, 29, 169, 365 and end-of-trialc Post-dose: day 1 and day 29 at 2 (1-3) h after dosing; day 169 and end-of-trialc at 2 (1-3) and 7 (4-10) h after dosing INPULSIS-1 [2] IPF; diagnosis ≤5 prior to screening visit 309 285 150 bid 100 bidb Pre-dose: days 29 and 169 Post-dose only): days 29 and 169 at 2-4 h after dosing INPULSIS-2 [2] IPF; diagnosis ≤5 years prior to screening visit 329 306 150 bid 100 bidb Pre-dose: days 29 and 169 Post-dose (Japan only): days 29 and 169 at 2-4 h after dosing qd, once daily; bid, twice daily; IPF, idiopathic pulmonary fibrosis a Treatment interruptions or 1-step dose reductions to manage adverse events were allowed: by 50 mg qd for subjects in the 50 mg qd or 50 mg bid and by 50 mg bid for those in the 100 mg bid or 150 mg bid group. No dose reescalation was allowed. b Treatment interruptions or 1-step dose reductions to manage adverse events were allowed: by 50 mg bid to 100 mg bid and then increased again to 150 mg bid after recovery. c End-of trial was day 365 unless a patient discontinued, in which case samples were taken on the day of discontinuation.
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