Table 2 Assessments
Parameters (if appropriate/if performed) | Inclusion documentation | Follow up documentations every 6 months |
|---|---|---|
Date of documentation | By EDC | By EDC |
Date of Informed Consent | X | |
Date of visit / contact with patient | X | X |
Eligibility criteria | X | |
Demographics | X | |
Physical examination | X | X |
ILD characterization Baseline information (diagnostic procedures) Symptoms Etiology | X | X |
Diagnostic procedures HRCT (details t.b.d.) Other | X | X |
Lung function FVC DLco FEV1, other | X | X |
Exercise capacity 6-min walk distance | X | X |
Concomitant diseases | X | X |
Treatment History Current medication for ILD (immunosuppression, antifibrotic) Concomitant medication (anticoagulation etc.) O2 Non-pharmacological management | X | X |
QoL 0–100 VAS Other instruments in substudies | X | X |
Clinical events Exacerbations Hospitalization due to ILD Cardiovascular events Deaths | X | |
Laboratory assessments, including CRP LDH Differential blood cell count (lymphocytes, neutrophils, eosinophils, monocytes), BAL differential cell count (as available) | X | X |
Safety Reporting for nintedanib Adverse Drug Reactions Fatal Adverse Events Pregnancy | X | X |
Survival status | X |