Common use of Safety Elements Clause in Contracts

Safety Elements. ‌ 15.1 Adverse Events‌ Previous studies of emphysema patients who were followed longitudinally and treated using medical management [10,16,17], diagnostic or interventional bronchoscopy [448,49], or endobronchial valves [16,17] indicate that a moderate risk of adverse events may be anticipated during this study. Adverse events will be graded by defining their severity and relatedness to the study device. It is anticipated that the rates for adverse events will be higher for the study treatment arm than control arm during the treatment period (‘short’, or day of the study procedure to 45 days) but that the rates for these occurrences will be similar for both study arms during the post-treatment period (‘long’, or 46 days to 1 year). Adverse events that may be observed include: ❖ Cardiovascular events such as: o New onset cardiac arrhythmia o New diagnosis of congestive heart failure, which may be indicated by >1-point increase in NYHA functional classification score o Acute myocardial infarct requiring medical care o New diagnosis transient ischemia attack (TIA) or stroke o New diagnosis deep vein thrombosis o Pulmonary embolism, which may be indicated by direct clinical evidence or V/Q evidence of segmental or larger perfusion defects ❖ COPD and Emphysema events such as: o COPD exacerbation requiring treatment with antibiotics and/or oral steroids ▪ AECOPD requiring emergency room visit or hospitalization o Respiratory failure requiring re-intubation at any time during follow-up and/or invasive mechanical ventilation >24 hours after the bronchoscopy procedure o Pneumonia requiring treatment with antibiotics, indicated by consolidation on X- ray or CT scan and clinical characteristics of active infection (fever, leukocytosis, hypotension) ❖ Pulmonary / Thoracic events such as: o Hemoptysis requiring new evaluation or intervention o Pneumothorax indicated by clinical symptoms and/or X-ray ▪ Pneumothorax requiring intervention o Empyema requiring new evaluation or intervention o Non-cardiac chest pain driving the study participant to seek medical care o Pleural effusion noted radiologically o Lung mass / cancer noted radiologically o Fractured rib noted radiologically o Laryngospasm driving the study participant to seek medical care o Dysphonia driving the study participant to seek medical care o Hypoxemia requiring increased or new oxygen use o Adverse tracheobronchial observations such as bronchial granulation tissue, bronchial ulceration, bronchial trauma ❖ Other events such as: o Death, any cause o Septicemia as evidenced by constitutional signs and symptoms consistent with bloodstream infection (with at least two separate blood cultures positive for the same pathogen(s), requiring systemic antimicrobial therapy) o Non-pulmonary infection requiring medical care o Fever > 99.5 ⁰C for > 24 hours ❖ Endobronchial Valve events such as: o Valve expectoration, as reported by the study participant o Valve migration, as indicated by clinical and/or radiological evidence that a valve has left the target airway o Pneumonia distal to implanted valves, indicated by consolidation on X-ray or CT scan and clinical characteristics of active infection (fever, leukocytosis, hypotension)