Mean (SD) FVC at the start of SENSCIS was 72.4 and 72.7 % predicted in the nintedanib and placebo groups, respectively.

Patients from the drug–drug interaction study were not included in this figure.

Mean (SD) off-treatment period between SENSCIS and SENSCIS-ON was 47.2 (17.9) and 49.6 (19.3) days in patients who continued and initiated nintedanib in SENSCIS-ON, respectively. From week 52, data from SENSCIS-ON were included in both arms as patients transitioned into the open-label study. For patients who initiated nintedanib in SENSCIS-ON, the duration of placebo treatment in SENSCIS was 52 to 100 weeks and the duration of nintedanib treatment in SENSCIS-ON was 0 to 48 weeks.

Proposed thresholds for worsening of FVC, stable FVC and improvement in FVC based on data from Scleroderma Lung Studies I and II, anchored to the health transition question from the Medical Outcomes Short Form-36.²

Adverse events were coded according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) except for “liver test abnormalities”, which was based on the standardized MedDRA query “liver related investigations, signs and symptoms” (broad definition). Data are % of patients with ≥1 such event reported over 52 weeks (or until 28 days after last drug intake if earlier in SENSCIS, or until 7 days after last trial drug intake if earlier in SENSCIS-ON). Events reported in >10% of patients in either group in SENSCIS-ON are shown.

Data are % of patients who had ≥1 diarrhea adverse event over 52 weeks (or until 7 days after last trial drug intake for patients who discontinued trial drug before week 52).

Permanent discontinuations were assessed up to week 52.